Use of dimdazenil or pharmaceutically acceptable salt thereof

Abstract

Provided is a method for treating insomnia comorbid with mental or nervous system disorders and / or insomnia comorbid with depressive episodes induced by mental or nervous system disorders. Administering to a subject an effective amount of dimdazenil, a prodrug thereof, or a pharmaceutically acceptable salt thereof significantly increases the total sleep time and reduces the sleep latency.

Description

Use of a didacinib or a pharmaceutically acceptable salt thereof Technical Field

[0001] This invention belongs to the field of pharmaceuticals, specifically relating to a method for treating insomnia (specifically including primary insomnia, insomnia with mental or neurological disorders, and / or insomnia with depressive episodes of mental or neurological disorders) using didacinib, its prodrug, or a pharmaceutically acceptable salt thereof. Background Technology

[0002] Insomnia is a subjective experience characterized by dissatisfaction with sleep duration and / or quality despite adequate sleep opportunities and environment, which impairs daytime social functioning. Insomnia is one of the most common sleep problems, with main symptoms including difficulty falling asleep (sleep latency exceeding 30 minutes), sleep persistence disturbances (≥2 awakenings per night), early awakening, decreased sleep quality, and reduced total sleep time (usually less than 6.5 hours).

[0003] Currently, benzodiazepines Benzene and non-benzodiazepines These are the mainstream prescription drugs for treating insomnia, among which traditional benzodiazepines... These types of drugs have good sedative and hypnotic effects for insomnia patients, but they are prone to causing residual effects the following day. Didacinib, on the other hand, is a novel benzodiazepine. The receptor agonist, chemically named 7-chloro-3-(5-dimethylaminomethyl-[1,2,4]oxadiazol-3-yl)-5-methyl-4,5-dihydro-imidazo[1,5-α][1,4]benzodiazepine -6-keto, its structural formula is shown in Formula I.

[0004] Didacinib is a form of γ-aminobutyric acid A (GABA) A A partial positive allosteric modulator of the receptor, it can selectively act on the α1 subunit and partially activate GABA. A Receptors can prevent excessive nerve inhibition, resulting in less daytime functional impairment and adverse reactions.

[0005] Didacinib was approved for marketing in China in November 2023, with the approved indication being the short-term treatment of insomnia. Patent CN200880112316.2 discloses a treatment for sleep disorders, which discloses a study to evaluate the efficacy of didacinib in treating primary insomnia in adult patients. Further research into expanding didacinib's indications, providing more patients with a safer and more effective route of administration, and better benefiting patients, still has positive scientific and social significance. Summary of the Invention

[0006] The present invention mainly provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for treating insomnia with mental or neurological disorders and / or insomnia with depressive episodes of mental or neurological disorders, or for the treatment of insomnia with mental or neurological disorders and / or insomnia with depressive episodes of mental or neurological disorders.

[0007] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for increasing total sleep time in patients with insomnia accompanied by mental or neurological disorders or for increasing total sleep time in patients with insomnia accompanied by depressive episodes of mental or neurological disorders;

[0008] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing sleep latency in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders;

[0009] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving somnolence in patients with insomnia accompanied by mental or neurological disorders and / or in patients with insomnia accompanied by depressive episodes of mental or neurological disorders; or for relieving somnolence in patients with insomnia accompanied by mental or neurological disorders and / or in patients with insomnia accompanied by depressive episodes of mental or neurological disorders.

[0010] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving fatigue in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders; or for relieving fatigue in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders.

[0011] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving cognitive function in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders; or for improving cognitive function in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders.

[0012] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing sleep-wake time in patients with insomnia accompanied by mental or neurological disorders or for reducing sleep-wake time in patients with insomnia accompanied by depressive episodes of mental or neurological disorders.

[0013] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing the number of sleep awakenings in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders;

[0014] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving sleep efficiency in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders, or for improving sleep efficiency in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders.

[0015] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing the severity of insomnia in patients with insomnia accompanied by mental or neurological disorders and / or the severity of insomnia in patients with insomnia accompanied by depressive episodes of mental or neurological disorders; or for reducing the severity of insomnia in patients with insomnia accompanied by mental or neurological disorders and / or the severity of insomnia in patients with insomnia accompanied by depressive episodes of mental or neurological disorders.

[0016] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving mobility in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders; or for improving mobility in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders.

[0017] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the self-care ability of patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders, or for improving the self-care ability of patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders.

[0018] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the daily activity capacity of patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders, or for improving the daily activity capacity of patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders.

[0019] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving pain or discomfort in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders; or for relieving pain or discomfort in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders.

[0020] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving anxiety or depression in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders; or for relieving anxiety or depression in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders.

[0021] This invention also provides the use of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the health status of patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders; wherein, the mental or neurological disorder may be:

[0022] Depression (depressive disorder or depressive disorder), such as major depressive disorder (MDD), persistent depressive disorder, and / or seasonal affective disorder;

[0023] and or,

[0024] Bipolar disorder (BD), such as bipolar I and / or bipolar II;

[0025] and or,

[0026] Anxiety disorders, such as separation anxiety disorder, agoraphobia, generalized anxiety disorder (GAD), social anxiety disorder (SAD), panic disorder, phobias, and / or substance / drug-induced anxiety disorders;

[0027] and or,

[0028] Somatic symptoms disorder;

[0029] and or,

[0030] Obsessive-compulsive disorder and related disorders, such as obsessive-compulsive disorder (OCD) and / or physical dysmorphic disorder (BDD);

[0031] and or,

[0032] Post-traumatic stress disorder (PTSD);

[0033] and or,

[0034] Pain disorders, such as chronic pain, fibromyalgia, and / or migraine;

[0035] and or,

[0036] Mental and behavioral disorders resulting from the use of psychoactive substances, such as substance use disorder (SUD);

[0037] and or,

[0038] Psychotic disorders, such as schizophrenia;

[0039] and or,

[0040] Eating disorders;

[0041] and or,

[0042] Attention deficit hyperactivity disorder (ADHD);

[0043] and or,

[0044] Personality disorders, such as schizotypal personality disorder and / or borderline personality disorder;

[0045] and or,

[0046] Autism spectrum disorder;

[0047] and or,

[0048] Chronic fatigue syndrome;

[0049] and or,

[0050] Mental disorders or mental or neurological disorders associated with HIV, COVID sequelae, or traumatic brain injury;

[0051] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for treating insomnia with depression, or for the treatment of insomnia with depression.

[0052] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for increasing total sleep time in patients with depression-related insomnia, or for increasing total sleep time in patients with depression-related insomnia.

[0053] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing sleep latency in patients with depression-associated insomnia, or for reducing sleep latency in patients with depression-associated insomnia.

[0054] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving drowsiness in patients with depression and insomnia, or for relieving drowsiness in patients with depression and insomnia;

[0055] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving fatigue in patients with depression and insomnia, or for relieving fatigue in patients with depression and insomnia.

[0056] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving cognitive function in patients with depression and insomnia, or for improving cognitive function in patients with depression and insomnia.

[0057] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing sleep-wake time in patients with depression-associated insomnia, or for reducing sleep-wake time in patients with depression-associated insomnia.

[0058] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing the number of sleep awakenings in patients with depression-related insomnia, or for reducing the number of sleep awakenings in patients with depression-related insomnia.

[0059] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving sleep efficiency in patients with depression and insomnia, or for improving sleep efficiency in patients with depression and insomnia.

[0060] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing the severity of insomnia in patients with depression or for reducing the severity of insomnia in patients with depression.

[0061] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving mobility in patients with depression and insomnia, or for improving mobility in patients with depression and insomnia.

[0062] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the self-care ability of patients with depression and insomnia, or for improving the self-care ability of patients with depression and insomnia.

[0063] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the daily activity capacity of patients with depression and insomnia, or for improving the daily activity capacity of patients with depression and insomnia.

[0064] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving pain or discomfort in patients with depression and insomnia, or for relieving pain or discomfort in patients with depression and insomnia.

[0065] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving anxiety or depression in patients with insomnia and depression, or for relieving anxiety or depression in patients with insomnia and depression.

[0066] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the health status of patients with depression and insomnia, or for improving the health status of patients with depression and insomnia.

[0067] In this invention, the insomnia accompanied by depression can be insomnia accompanied by major depressive disorder (MDD), insomnia accompanied by persistent depressive disorder, and / or insomnia accompanied by seasonal affective disorder;

[0068] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for treating insomnia with depressive episodes, or for the treatment of insomnia with depressive episodes.

[0069] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for increasing total sleep time in patients with insomnia accompanied by depressive episodes, or for increasing total sleep time in patients with insomnia accompanied by depressive episodes.

[0070] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing sleep latency in patients with insomnia accompanied by depressive episodes, or for reducing sleep latency in patients with insomnia accompanied by depressive episodes.

[0071] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving somnolence in patients with insomnia accompanied by depressive episodes, or for relieving somnolence in patients with insomnia accompanied by depressive episodes;

[0072] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving fatigue in patients with insomnia accompanied by depressive episodes, or for relieving fatigue in patients with insomnia accompanied by depressive episodes.

[0073] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving cognitive function in patients with insomnia accompanied by depressive episodes, or for improving cognitive function in patients with insomnia accompanied by depressive episodes.

[0074] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing sleep-wake time in patients with insomnia accompanied by depressive episodes, or for reducing sleep-wake time in patients with insomnia accompanied by depressive episodes.

[0075] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing the number of sleep awakenings in patients with insomnia accompanied by depressive episodes, or for reducing the number of sleep awakenings in patients with insomnia accompanied by depressive episodes.

[0076] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving sleep efficiency in patients with insomnia accompanied by depressive episodes, or for improving sleep efficiency in patients with insomnia accompanied by depressive episodes.

[0077] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing the severity of insomnia in patients with insomnia accompanied by depressive episodes, or for reducing the severity of insomnia in patients with insomnia accompanied by depressive episodes.

[0078] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the mobility of patients with insomnia accompanied by depressive episodes, or for improving the mobility of patients with insomnia accompanied by depressive episodes.

[0079] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the self-care ability of patients with insomnia accompanied by depressive episodes, or for improving the self-care ability of patients with insomnia accompanied by depressive episodes.

[0080] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the daily activity capacity of patients with insomnia accompanied by depressive episodes, or for improving the daily activity capacity of patients with insomnia accompanied by depressive episodes.

[0081] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving pain or discomfort in patients with insomnia accompanied by depressive episodes, or for relieving pain or discomfort in patients with insomnia accompanied by depressive episodes.

[0082] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving anxiety or depression in patients with insomnia accompanied by depressive episodes, or for relieving anxiety or depression in patients with insomnia accompanied by depressive episodes.

[0083] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the health status of patients with insomnia accompanied by depressive episodes, or for improving the health status of patients with insomnia accompanied by depressive episodes.

[0084] In this invention, the insomnia accompanied by depressive episodes can be insomnia accompanied by major depressive disorder (MDD), insomnia accompanied by persistent depressive disorder, and / or insomnia accompanied by seasonal affective disorder.

[0085] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for treating insomnia with bipolar disorder, or for the treatment of insomnia with bipolar disorder.

[0086] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for increasing total sleep time in patients with insomnia due to bipolar disorder, or for increasing total sleep time in patients with insomnia due to bipolar disorder.

[0087] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing sleep latency in patients with bipolar disorder-associated insomnia, or for reducing sleep latency in patients with bipolar disorder-associated insomnia.

[0088] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving somnolence in patients with insomnia due to bipolar disorder, or for relieving somnolence in patients with insomnia due to bipolar disorder;

[0089] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving fatigue in patients with insomnia associated with bipolar disorder, or for relieving fatigue in patients with insomnia associated with bipolar disorder.

[0090] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving cognitive function in patients with insomnia with bipolar disorder, or for improving cognitive function in patients with insomnia with bipolar disorder.

[0091] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing sleep-wake time in patients with insomnia associated with bipolar disorder, or for reducing sleep-wake time in patients with insomnia associated with bipolar disorder.

[0092] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing the number of sleep awakenings in patients with bipolar disorder-related insomnia, or for reducing the number of sleep awakenings in patients with bipolar disorder-related insomnia.

[0093] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving sleep efficiency in patients with insomnia due to bipolar disorder, or for improving sleep efficiency in patients with insomnia due to bipolar disorder.

[0094] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing the severity of insomnia in patients with bipolar disorder, or for reducing the severity of insomnia in patients with bipolar disorder.

[0095] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the mobility of patients with insomnia due to bipolar disorder, or for improving the mobility of patients with insomnia due to bipolar disorder.

[0096] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the self-care ability of patients with insomnia accompanied by bipolar disorder, or for improving the self-care ability of patients with insomnia accompanied by bipolar disorder.

[0097] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the daily activities of patients with insomnia accompanied by bipolar disorder, or for improving the daily activities of patients with insomnia accompanied by bipolar disorder.

[0098] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving pain or discomfort in patients with insomnia associated with bipolar disorder, or for relieving pain or discomfort in patients with insomnia associated with bipolar disorder.

[0099] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving anxiety or depression in patients with insomnia associated with bipolar disorder, or for relieving anxiety or depression in patients with insomnia associated with bipolar disorder.

[0100] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the health status of patients with insomnia associated with bipolar disorder, or for improving the health status of patients with insomnia associated with bipolar disorder.

[0101] In this invention, insomnia with bipolar disorder can be bipolar I insomnia and / or bipolar II insomnia;

[0102] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for treating insomnia with bipolar disorder depressive episodes, or for the treatment of insomnia with bipolar disorder depressive episodes.

[0103] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for increasing total sleep time in patients with insomnia due to bipolar disorder and depressive episodes, or for increasing total sleep time in patients with insomnia due to bipolar disorder and depressive episodes.

[0104] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing sleep latency in patients with insomnia due to bipolar disorder and depressive episodes, or for reducing sleep latency in patients with insomnia due to bipolar disorder and depressive episodes.

[0105] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving somnolence in patients with insomnia due to bipolar disorder and depressive episodes, or for relieving somnolence in patients with insomnia due to bipolar disorder and depressive episodes.

[0106] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving fatigue in patients with insomnia due to bipolar disorder and depressive episodes, or for relieving fatigue in patients with insomnia due to bipolar disorder and depressive episodes.

[0107] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving cognitive function in patients with insomnia accompanied by bipolar disorder and depressive episodes, or for improving cognitive function in patients with insomnia accompanied by bipolar disorder and depressive episodes.

[0108] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing sleep-wake time in patients with insomnia due to bipolar disorder and depressive episodes, or for reducing sleep-wake time in patients with insomnia due to bipolar disorder and depressive episodes.

[0109] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing the number of sleep awakenings in patients with insomnia accompanied by bipolar disorder and depressive episodes, or for reducing the number of sleep awakenings in patients with insomnia accompanied by bipolar disorder and depressive episodes.

[0110] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving sleep efficiency in patients with insomnia due to bipolar disorder and depressive episodes, or for improving sleep efficiency in patients with insomnia due to bipolar disorder and depressive episodes.

[0111] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing the severity of insomnia in patients with bipolar disorder-induced depressive episodes, or for reducing the severity of insomnia in patients with bipolar disorder-induced depressive episodes.

[0112] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the mobility of patients with bipolar disorder-induced depression and insomnia, or for improving the mobility of patients with bipolar disorder-induced depression and insomnia.

[0113] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the self-care ability of patients with insomnia accompanied by bipolar disorder and depressive episodes, or for improving the self-care ability of patients with insomnia accompanied by bipolar disorder and depressive episodes.

[0114] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the daily activity capacity of patients with bipolar disorder and insomnia with depressive episodes, or for improving the daily activity capacity of patients with bipolar disorder and insomnia with depressive episodes.

[0115] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving pain or discomfort in patients with insomnia accompanied by bipolar disorder and depressive episodes, or for relieving pain or discomfort in patients with insomnia accompanied by bipolar disorder and depressive episodes.

[0116] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving anxiety or depression in patients with insomnia due to bipolar disorder and depressive episodes, or for relieving anxiety or depression in patients with insomnia due to bipolar disorder and depressive episodes.

[0117] The present invention also provides the use of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the health status of patients with insomnia due to bipolar disorder depressive episodes, or for improving the health status of patients with insomnia due to bipolar disorder depressive episodes; in the present invention, insomnia due to bipolar disorder depressive episodes may be insomnia due to bipolar I depressive episodes and / or insomnia due to bipolar II depressive episodes; the present invention also provides the use of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof for the preparation of a medicament for treating patients with insomnia, or for treating patients with insomnia;

[0118] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for increasing total sleep time in patients with insomnia, or for increasing total sleep time in patients with insomnia;

[0119] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing sleep latency in patients with insomnia, or for reducing sleep latency in patients with insomnia.

[0120] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving drowsiness in patients with insomnia, or for relieving drowsiness in patients with insomnia;

[0121] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving fatigue in patients with insomnia, or for relieving fatigue in patients with insomnia.

[0122] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving cognitive function in patients with insomnia, or for improving cognitive function in patients with insomnia.

[0123] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing sleep-wake time in patients with insomnia, or for reducing sleep-wake time in patients with insomnia.

[0124] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing the number of sleep awakenings in patients with insomnia, or for reducing the number of sleep awakenings in patients with insomnia.

[0125] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving sleep efficiency in patients with insomnia, or for improving sleep efficiency in patients with insomnia.

[0126] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for reducing the severity of insomnia in patients with insomnia, or for reducing the severity of insomnia in patients with insomnia.

[0127] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the mobility of patients with insomnia, or for improving the mobility of patients with insomnia.

[0128] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the self-care ability of insomnia patients, or for improving the self-care ability of insomnia patients.

[0129] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the daily activity capacity of patients with insomnia, or for improving the daily activity capacity of patients with insomnia.

[0130] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving pain or discomfort in patients with insomnia, or for relieving pain or discomfort in patients with insomnia.

[0131] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for relieving anxiety or depression in patients with insomnia, or for relieving anxiety or depression in patients with insomnia.

[0132] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for improving the health status of patients with insomnia, or for improving the health status of patients with insomnia.

[0133] The present invention also provides the use of didacinib, its prodrug or a pharmaceutically acceptable salt thereof for the preparation of a medicament for treating patient anxiety, or for the treatment of patient anxiety;

[0134] In this invention, the dosage form of the drug shown can be an injectable dosage form or an oral dosage form;

[0135] In this invention, the oral dosage form is a tablet, pill, lozenge, capsule, liquid, gel, syrup, ointment, or suspension, preferably a tablet or capsule;

[0136] In this invention, the dosage or content of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof in the drug is from about 0.5 mg to about 5 mg, specifically from about 1.0 mg to about 4.5 mg, from about 1.5 mg to about 4 mg, from about 2 mg to about 3.5 mg, from about 2.5 mg to about 3 mg, or any range of all the above amounts; for example, it may be from about 0.5 mg or from about 1.5 mg to about 5 mg, from about 4.5 mg, from about 4 mg, from about 3.5 mg, from about 3 mg, or from about 2.5 mg; preferably, from about 1 mg to about 3 mg, more preferably from about 1.5 mg to about 2.5 mg;

[0137] In this invention, the drug may contain only didacinib, its prodrug, or a pharmaceutically acceptable salt thereof as an active ingredient; or it may contain didacinib, its prodrug, or a pharmaceutically acceptable salt thereof, and one or more other active ingredients.

[0138] The other active ingredients may be drugs for treating mental or nervous system disorders, preferably drugs for treating depression, drugs for treating insomnia, drugs for treating bipolar disorder, etc.

[0139] In this invention, the drug is preferably taken orally before bedtime;

[0140] In this invention, "before going to sleep" refers to within 2 hours before bedtime, preferably within 1 hour before bedtime, more preferably within 30 minutes before bedtime, and even more preferably within 15 minutes before bedtime.

[0141] In this invention, the oral dose of the drug is from about 0.5 mg to about 5 mg each time, specifically from about 1.0 mg to about 4.5 mg, from about 1.5 mg to about 4 mg, from about 2 mg to about 3.5 mg, from about 2.5 mg to about 3 mg, or any range of all the above amounts; for example, the dose is from about 0.5 mg or about 1.5 mg to about 5 mg, from about 4.5 mg, from about 4 mg, from about 3.5 mg, from about 3 mg, or from about 2.5 mg; preferably, from about 1 mg to about 3 mg, more preferably from about 1.5 mg to about 2.5 mg;

[0142] In this invention, the drug is taken orally once, twice, three times, four times, five times, six times, or seven times per week; preferably, it is taken orally at least three times per week.

[0143] In this invention, the duration of oral administration of the drug can be 1 week, 2 weeks, 3 weeks, 4 weeks or longer;

[0144] The present invention also provides a method for treating insomnia with mental or neurological disorders and / or insomnia with depressive episodes of mental or neurological disorders, the method comprising administering to a subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0145] The present invention also provides a method for increasing the total sleep time of patients with insomnia accompanied by mental or neurological disorders or patients with insomnia accompanied by depressive episodes of mental or neurological disorders, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0146] The present invention also provides a method for reducing sleep latency in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia due to depressive episodes accompanied by mental or neurological disorders, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0147] The present invention also provides a method for relieving somnolence in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders, the method comprising administering to a subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0148] The present invention also provides a method for relieving fatigue in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0149] The present invention also provides a method for improving cognitive function in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0150] The present invention also provides a method for reducing sleep-wake time in patients with insomnia accompanied by mental or neurological disorders or in patients with insomnia accompanied by depressive episodes of mental or neurological disorders, the method comprising administering to a subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0151] The present invention also provides a method for reducing the number of sleep awakenings in patients with insomnia accompanied by mental or neurological disorders and / or in patients with insomnia accompanied by depressive episodes of mental or neurological disorders, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0152] The present invention also provides a method for improving sleep efficiency in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0153] The present invention also provides a method for reducing the severity of insomnia in patients with insomnia accompanied by mental or neurological disorders and / or the severity of insomnia in patients with insomnia accompanied by depressive episodes of mental or neurological disorders, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0154] The present invention also provides a method for improving the mobility of patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders, the method comprising administering to a subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0155] The present invention also provides a method for improving the self-care ability of insomnia patients with mental or neurological disorders and / or the self-care ability of insomnia patients with depressive episodes due to mental or neurological disorders, the method comprising administering to a subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0156] The present invention also provides a method for improving the daily activity ability of patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders, the method comprising administering to a subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0157] The present invention also provides a method for relieving pain or discomfort in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0158] The present invention also provides a method for relieving anxiety or depression in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0159] The present invention also provides a method for improving the health status of patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia accompanied by depressive episodes of mental or neurological disorders, the method comprising administering to a subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0160] In this invention, the mental or nervous system disorders are as defined or exemplified herein;

[0161] The present invention also provides a method for treating insomnia accompanied by depression, the method comprising administering to a subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof;

[0162] The present invention also provides a method for increasing total sleep time in patients with depression and insomnia, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0163] The present invention also provides a method for reducing sleep latency in patients with depression and insomnia, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0164] The present invention also provides a method for relieving somnolence in patients with depression and insomnia, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0165] The present invention also provides a method for relieving fatigue in patients with depression and insomnia, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0166] The present invention also provides a method for improving cognitive function in patients with depression and insomnia, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0167] The present invention also provides a method for reducing sleep-wake time in patients with depression and insomnia, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0168] The present invention also provides a method for reducing the number of sleep awakenings in patients with depression and insomnia, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0169] The present invention also provides a method for improving sleep efficiency in patients with depression and insomnia, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0170] The present invention also provides a method for reducing the severity of insomnia in patients with depression, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0171] The present invention also provides a method for improving the mobility of patients with depression and insomnia, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0172] The present invention also provides a method for improving the self-care ability of patients with depression and insomnia, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0173] The present invention also provides a method for improving the daily activity ability of patients with depression and insomnia, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0174] The present invention also provides a method for relieving pain or discomfort in patients with depression and insomnia, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0175] The present invention also provides a method for relieving anxiety or depression in patients with insomnia accompanied by depression, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0176] The present invention also provides a method for improving the health status of patients with depression and insomnia. The method includes administering to the subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof.

[0177] In this invention, the insomnia accompanied by depression can be insomnia accompanied by major depressive disorder (MDD), insomnia accompanied by persistent depressive disorder, and / or insomnia accompanied by seasonal affective disorder;

[0178] The present invention also provides a method for treating insomnia accompanied by depressive episodes, the method comprising administering to a subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof;

[0179] The present invention also provides a method for increasing total sleep time in patients with insomnia accompanied by depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof;

[0180] The present invention also provides a method for reducing sleep latency in patients with insomnia accompanied by depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof;

[0181] The present invention also provides a method for relieving somnolence in patients with insomnia accompanied by depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof;

[0182] The present invention also provides a method for relieving fatigue in patients with insomnia accompanied by depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0183] The present invention also provides a method for improving cognitive function in patients with insomnia accompanied by depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof;

[0184] The present invention also provides a method for reducing sleep-wake time in patients with insomnia accompanied by depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0185] The present invention also provides a method for reducing the number of sleep awakenings in patients with insomnia accompanied by depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0186] The present invention also provides a method for improving sleep efficiency in patients with insomnia accompanied by depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0187] The present invention also provides a method for reducing the severity of insomnia in patients with insomnia accompanied by depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0188] The present invention also provides a method for improving the mobility of patients with insomnia accompanied by depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0189] The present invention also provides a method for improving the self-care ability of patients with insomnia accompanied by depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0190] The present invention also provides a method for improving the daily activity ability of patients with insomnia accompanied by depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0191] The present invention also provides a method for relieving pain or discomfort in patients with insomnia accompanied by depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof;

[0192] The present invention also provides a method for relieving anxiety or depression in patients with insomnia accompanied by depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0193] The present invention also provides a method for improving the health status of patients with insomnia accompanied by depressive episodes. The method includes administering to the subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof.

[0194] In this invention, the insomnia accompanied by depressive episodes can be insomnia accompanied by major depressive disorder (MDD), insomnia accompanied by persistent depressive disorder, and / or insomnia accompanied by seasonal affective disorder.

[0195] The present invention also provides a method for treating insomnia associated with bipolar disorder, the method comprising administering to a subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof;

[0196] The present invention also provides a method for increasing total sleep time in patients with insomnia accompanied by bipolar disorder, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0197] The present invention also provides a method for reducing sleep latency in patients with insomnia accompanied by bipolar disorder, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0198] The present invention also provides a method for relieving somnolence in patients with insomnia accompanied by bipolar disorder, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0199] The present invention also provides a method for relieving fatigue in patients with insomnia accompanied by bipolar disorder, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0200] The present invention also provides a method for improving cognitive function in patients with insomnia accompanied by bipolar disorder, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0201] The present invention also provides a method for reducing sleep-wake time in patients with insomnia accompanied by bipolar disorder, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0202] The present invention also provides a method for reducing the number of sleep awakenings in patients with insomnia accompanied by bipolar disorder, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0203] The present invention also provides a method for improving sleep efficiency in patients with insomnia accompanied by bipolar disorder, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0204] The present invention also provides a method for reducing the severity of insomnia in patients with bipolar disorder, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0205] The present invention also provides a method for improving the mobility of patients with insomnia accompanied by bipolar disorder, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0206] The present invention also provides a method for improving the self-care ability of patients with insomnia accompanied by bipolar disorder, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0207] The present invention also provides a method for improving the daily activity ability of patients with insomnia accompanied by bipolar disorder, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0208] The present invention also provides a method for relieving pain or discomfort in patients with insomnia accompanied by bipolar disorder, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0209] The present invention also provides a method for relieving anxiety or depression in patients with insomnia accompanied by bipolar disorder, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0210] The present invention also provides a method for improving the health status of patients with insomnia accompanied by bipolar disorder. The method includes administering to the subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof.

[0211] In this invention, insomnia with bipolar disorder can be bipolar I insomnia and / or bipolar II insomnia;

[0212] The present invention also provides a method for treating insomnia associated with bipolar disorder and depressive episodes, the method comprising administering to a subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof;

[0213] The present invention also provides a method for increasing total sleep time in patients with insomnia accompanied by bipolar disorder and depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof;

[0214] The present invention also provides a method for reducing sleep latency in patients with insomnia accompanied by bipolar disorder and depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof;

[0215] The present invention also provides a method for relieving somnolence in patients with insomnia accompanied by bipolar disorder and depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0216] The present invention also provides a method for relieving fatigue in patients with insomnia accompanied by bipolar disorder and depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof;

[0217] The present invention also provides a method for improving cognitive function in patients with insomnia accompanied by bipolar disorder and depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0218] The present invention also provides a method for reducing sleep-wake time in patients with insomnia accompanied by bipolar disorder and depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof;

[0219] The present invention also provides a method for reducing the number of sleep awakenings in patients with insomnia accompanied by bipolar disorder and depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0220] The present invention also provides a method for improving sleep efficiency in patients with insomnia accompanied by bipolar disorder and depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0221] The present invention also provides a method for reducing the severity of insomnia in patients with bipolar disorder-associated depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof;

[0222] The present invention also provides a method for improving the mobility of patients with insomnia accompanied by bipolar disorder and depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0223] The present invention also provides a method for improving the self-care ability of patients with insomnia accompanied by bipolar disorder and depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0224] The present invention also provides a method for improving the daily activity ability of patients with insomnia accompanied by bipolar disorder and depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0225] The present invention also provides a method for relieving pain or discomfort in patients with insomnia accompanied by bipolar disorder and depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0226] The present invention also provides a method for relieving anxiety or depression in patients with insomnia accompanied by bipolar disorder and depressive episodes, the method comprising administering to the subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0227] The present invention also provides a method for improving the health status of patients with insomnia accompanied by bipolar disorder and depressive episodes. The method includes administering to the subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof.

[0228] In this invention, insomnia accompanied by bipolar disorder depressive episodes can be insomnia accompanied by bipolar I depressive episodes and / or insomnia accompanied by bipolar II depressive episodes;

[0229] The present invention also provides a method for treating insomnia, the method comprising administering to a subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof;

[0230] The present invention also provides a method for increasing the total sleep time of patients with insomnia, the method comprising administering to a subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0231] The present invention also provides a method for reducing sleep latency in patients with insomnia, the method comprising administering to a subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof;

[0232] The present invention also provides a method for relieving drowsiness in patients with insomnia, the method comprising administering to a subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0233] The present invention also provides a method for relieving fatigue in patients with insomnia, the method comprising administering to a subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0234] The present invention also provides a method for improving cognitive function in patients with insomnia, the method comprising administering to a subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0235] The present invention also provides a method for reducing sleep-wake time in patients with insomnia, the method comprising administering to a subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof;

[0236] The present invention also provides a method for reducing the number of awakenings during sleep in patients with insomnia, the method comprising administering to a subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof;

[0237] The present invention also provides a method for improving sleep efficiency in patients with insomnia, the method comprising administering to a subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0238] The present invention also provides a method for reducing the severity of insomnia in patients with insomnia, the method comprising administering to a subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0239] The present invention also provides a method for improving the mobility of insomnia patients, the method comprising administering to a subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0240] The present invention also provides a method for improving the self-care ability of insomnia patients, the method comprising administering to a subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0241] The present invention also provides a method for improving the daily activity ability of insomnia patients, the method comprising administering to a subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0242] The present invention also provides a method for relieving pain or discomfort in patients with insomnia, the method comprising administering to a subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0243] The present invention also provides a method for relieving anxiety or depression in patients with insomnia, the method comprising administering to a subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0244] The present invention also provides a method for improving the health status of patients with insomnia, the method comprising administering to a subject an effective amount of didacinib, its prodrug or a pharmaceutically acceptable salt thereof;

[0245] The present invention also provides a method for treating anxiety, the method comprising administering to a subject an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof;

[0246] In this invention, administering an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof to a subject may be either direct administration of an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof to the subject, or administration of a pharmaceutical composition comprising an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof to the subject.

[0247] Optionally, the pharmaceutical composition may also contain a pharmaceutically acceptable carrier and / or excipients;

[0248] In this invention, the dosage form of the pharmaceutical composition shown can be an injectable dosage form or an oral dosage form;

[0249] In this invention, the oral dosage form is a tablet, pill, lozenge, capsule, liquid, gel, syrup, ointment, or suspension, preferably a tablet or capsule;

[0250] In this invention, the amount of effective dose of didacinib, its prodrug, or its pharmaceutically acceptable salt may vary depending on the severity of the symptoms to be relieved and on factors such as the subject's disease state, age, sex, and weight.

[0251] Specifically, the effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof may be from about 0.5 mg to about 5 mg, specifically from about 1.0 mg to about 4.5 mg, from about 1.5 mg to about 4 mg, from about 2 mg to about 3.5 mg, from about 2.5 mg to about 3 mg, or any range of all the above amounts. For example, the effective amount is from about 0.5 mg or about 1.5 mg to about 5 mg, from about 4.5 mg, from about 4 mg, from about 3.5 mg, from about 3 mg, or from about 2.5 mg. Preferably, it is from about 1 mg to about 3 mg, more preferably from about 1.5 mg to about 2.5 mg;

[0252] In this invention, the application is preferably taken before bedtime; more preferably, it is taken orally before bedtime.

[0253] In this invention, "before going to sleep" refers to within 2 hours before bedtime, preferably within 1 hour before bedtime, more preferably within 30 minutes before bedtime, and even more preferably within 15 minutes before bedtime.

[0254] In this invention, the application is preferably performed once, twice, three times, four times, five times, six times, or seven times per week; more preferably at least three times per week.

[0255] In this invention, the duration of application can be 1 week, 2 weeks, 3 weeks, 4 weeks or longer;

[0256] In this invention, the term "subject" is intended to include any animal, and in some embodiments, the subject is a human or non-human mammal, such as a mouse, rat, other rodent, rabbit, dog, cat, pig, cow, sheep, horse, or primate.

[0257] In this invention, the prodrug refers to a compound that has no or low activity in vitro after being chemically modified, but releases an active drug in vivo through enzymatic or non-enzymatic conversion to exert its pharmacological effect.

[0258] In this invention, pharmaceutically acceptable salts of didacini can be prepared using standard techniques well known to those skilled in the art; specifically, pharmaceutically acceptable salts are acid addition salts, such as salts formed with inorganic or organic acids; examples of such pharmaceutically acceptable salts include hydrochloride, hydrobromide, sulfate, nitrate, citrate, acetate, maleate, fumarate, tartrate, succinate, methanesulfonate, or p-toluenesulfonate, etc.

[0259] In this invention, the total sleep time can be the subjective total sleep time;

[0260] In this invention, the sleep latency period can be the subjective sleep latency period.

[0261] The positive and progressive effects of this invention are as follows:

[0262] This invention provides a method for treating insomnia accompanied by mental or neurological disorders and / or insomnia accompanied by depressive episodes of mental or neurological disorders. By administering an effective amount of didacini, its prodrug, or a pharmaceutically acceptable salt thereof to the subject, a good therapeutic effect can be achieved, significantly increasing total sleep time and reducing sleep latency.

[0263] This invention provides a method for treating insomnia accompanied by mental or neurological disorders and / or insomnia accompanied by depressive episodes of mental or neurological disorders. By administering an effective amount of didacini, its prodrug, or a pharmaceutically acceptable salt thereof to the subject, a good therapeutic effect can be achieved, effectively relieving drowsiness and fatigue, and improving cognitive function.

[0264] This invention provides a method for treating insomnia accompanied by mental or neurological disorders and / or insomnia accompanied by depressive episodes of mental or neurological disorders. By administering an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof to the subject, a good therapeutic effect can be achieved, significantly reducing sleep-wake time and the number of sleep-wake cycles, effectively improving sleep efficiency, and significantly reducing the severity of insomnia.

[0265] This invention provides a method for treating insomnia accompanied by mental or neurological disorders and / or insomnia accompanied by depressive episodes of mental or neurological disorders. By administering an effective amount of didacini, its prodrug, or a pharmaceutically acceptable salt thereof to the subject, it can achieve good therapeutic effects, significantly improve mobility, self-care ability, daily activity ability, and effectively relieve pain or discomfort.

[0266] This invention provides a method for treating insomnia accompanied by mental or neurological disorders and / or insomnia accompanied by depressive episodes of mental or neurological disorders. By administering an effective amount of didacini, its prodrug, or a pharmaceutically acceptable salt thereof to the subject, a good therapeutic effect can be achieved, effectively relieving anxiety or depression and significantly improving health status.

[0267] This invention provides a method for treating anxiety, which can achieve good therapeutic effects, effectively relieve anxiety, and significantly improve health status by administering an effective amount of didacinib, its prodrug, or a pharmaceutically acceptable salt thereof to the subject. Specific Implementation

[0268] Example 1

[0269] This study employed a single-center, open-label, randomized controlled design to evaluate the efficacy and safety of didacinib in treating insomnia, as well as its impact on daytime functioning in insomnia patients.

[0270] Study population:

[0271] Patients aged ≥18 and ≤65 years who are outpatients or inpatients with primary insomnia or insomnia accompanied by depressive episodes / bipolar disorder with depressive episodes;

[0272] Table 1 Number of patients enrolled

[0273] Drug: Didacinib capsules, 2.5mg (Manufacturer: Zhejiang Jingxin Pharmaceutical Co., Ltd., Trade Name: );

[0274] Dosage: Take 2.5 mg orally before bedtime, at least 3 times a week;

[0275] Table 2 Follow-up Plan

[0276] Key indicators:

[0277] On day 14, the change in total sleep time (sTST) from baseline was subjectively recorded;

[0278] The change in total sleep time (sTST) from baseline during the last subjective recording;

[0279] On day 14, the change in total sleep time (sTST) was subjectively recorded from 390 minutes.

[0280] The change in total sleep time (sTST) from the last subjective recording to 390 minutes;

[0281] Secondary indicators:

[0282] 1. Daytime functional indicators

[0283] 1) Change in the Epworth Sleepiness Scale score on day 14 from baseline;

[0284] 2) Changes in fatigue assessment (Flinders Fatigue Scale) scores on day 14 from baseline;

[0285] 3) Changes in daytime attention and working memory function assessment (Digit Symbol Substitution Test (DSST)) scores on day 14 compared to baseline;

[0286] 4) Changes in cognitive function assessment (TMT-A) scores on day 14 compared to baseline;

[0287] 5) Change in the last sleepiness assessment (Epworth Sleepiness Scale) score from baseline;

[0288] 6) Change in the score of the last fatigue assessment (Flinders Fatigue Scale) from the baseline;

[0289] 7) Change in the score of the last daytime attention and working memory function assessment (Digit Symbol Substitution Test (DSST)) from baseline;

[0290] 8) Change in the score of the last cognitive function assessment (Template Test-A (TMT-A)) from baseline;

[0291] 2. Sleep indicators

[0292] On day 14, the changes in subjective sleep latency (sSL), sleep wake time (sWASO), number of sleep awakenings (sNAW), sleep efficiency (sSE), and insomnia severity index (ISI) scores from baseline in the sleep diary;

[0293] Changes from baseline in the subjective sleep latency (sSL), sleep-wake time (sWASO), sleep-wake frequency (sNAW), sleep efficiency (sSE), and insomnia severity index (ISI) scores of the last sleep diary;

[0294] The statistical results of the study are as follows:

[0295] Table 3. Analysis of the change in total sleep time from the last subjective recording to 390 minutes (FAS)

[0296] Table 4. Analysis of the change in subjective sleep latency from baseline in the last sleep diary entry (FAS)

[0297] As shown in Tables 3 and 4, didacinib can prolong the total sleep time and shorten the sleep latency of insomnia patients (specifically including patients with primary insomnia, patients with insomnia accompanied by depressive episodes / bipolar disorder). Among them, comparing patients with primary insomnia and patients with insomnia accompanied by depressive episodes / bipolar disorder, it can be found that didacinib is more effective in treating patients with insomnia accompanied by depressive episodes and patients with insomnia accompanied by depressive episodes / bipolar disorder, and can increase the total sleep time more and have a shorter sleep latency.

[0298] Example 2

[0299] This study employed a single-center, open-label, randomized controlled design to evaluate the efficacy and safety of didacinib in treating insomnia, as well as its impact on daytime functioning in insomnia patients.

[0300] Study population:

[0301] Patients aged ≥18 and ≤65 years who are outpatients or inpatients with primary insomnia or insomnia accompanied by depressive episodes / bipolar disorder with depressive episodes;

[0302] Table 5 Number of patients enrolled

[0303] Drug: Didacinib capsules, 2.5mg (Manufacturer: Zhejiang Jingxin Pharmaceutical Co., Ltd., Trade Name: );

[0304] Dosage: Take 2.5 mg orally before bedtime, at least 3 times a week;

[0305] Table 6 Follow-up Plan

[0306] Key indicators:

[0307] On day 14, the change in total sleep time (sTST) from baseline was subjectively recorded;

[0308] The change in total sleep time (sTST) from baseline during the last subjective recording;

[0309] On day 14, the change in total sleep time (sTST) was subjectively recorded from 390 minutes.

[0310] The change in total sleep time (sTST) from the last subjective recording to 390 minutes;

[0311] Secondary indicators:

[0312] 1. Daytime functional indicators

[0313] 9) Change in the Epworth Sleepiness Scale score on day 14 from baseline;

[0314] 10) Change in fatigue assessment (Flinders Fatigue Scale) score on day 14 from baseline;

[0315] 11) Changes in daytime attention and working memory function assessment (Digit Symbol Substitution Test (DSST)) scores on day 14 from baseline;

[0316] 12) Changes in cognitive function assessment (Tracing Test-A (TMT-A)) scores on day 14 compared to baseline;

[0317] 13) Change in the last sleepiness assessment (Epworth Sleepiness Scale) score from baseline;

[0318] 14) Change in the score of the last fatigue assessment (Flinders Fatigue Scale) from baseline;

[0319] 15) Change in the score of the last daytime attention and working memory function assessment (Digit Symbol Substitution Test (DSST)) from baseline;

[0320] 16) Change in the score of the last cognitive function assessment (Template Test-A (TMT-A)) from baseline;

[0321] 2. Sleep indicators

[0322] On day 14, the changes in subjective sleep latency (sSL), sleep wake time (sWASO), number of sleep awakenings (sNAW), sleep efficiency (sSE), and insomnia severity index (ISI) scores from baseline in the sleep diary;

[0323] Changes from baseline in the subjective sleep latency (sSL), sleep-wake time (sWASO), sleep-wake frequency (sNAW), sleep efficiency (sSE), and insomnia severity index (ISI) scores of the last sleep diary;

[0324] 3. Individual Quality of Life Scales (EQ-5D-5L)

[0325] Changes in mobility, self-care, daily activities, pain or discomfort, anxiety or depression, and health status scores from baseline;

[0326] The statistical results of the study are as follows:

[0327] Table 7. Analysis of the change in total score of the Epworth Sleepiness Scale (FAS) on day 14 post-baseline.

[0328] As shown in Table 7, didacinib helps alleviate or reduce drowsiness symptoms in insomnia patients (specifically including patients with primary insomnia, patients with insomnia accompanied by depressive episodes / bipolar disorder depressive episodes, etc.).

[0329] Table 8. Analysis of the change in total fatigue assessment (Flinders Fatigue Scale) score from baseline on day 14 post-baseline (FAS)

[0330] As shown in Table 8, didacinib helps relieve fatigue symptoms in insomnia patients (specifically including patients with primary insomnia, patients with insomnia accompanied by depressive episodes / bipolar disorder depressive episodes, etc.), thus improving or alleviating these symptoms.

[0331] Table 9. Analysis of the change in completion time (seconds) of cognitive function assessment (Template Test-A (TMT-A)) from baseline on day 14 after baseline (FAS)

[0332] As shown in Table 9, didacinib helps improve or enhance the cognitive function of insomnia patients (specifically including patients with primary insomnia, patients with insomnia accompanied by depressive episodes / bipolar disorder depressive episodes, etc.).

[0333] Table 10 Analysis of changes in sleep-wake time (sWASO) from baseline on day 14 after baseline (FAS) in sleep diaries

[0334] Table 10 shows that didacinib helps reduce sleep-wake time in insomnia patients (specifically including patients with primary insomnia, patients with insomnia accompanied by depressive episodes / bipolar disorder). Among them, comparing patients with primary insomnia and patients with insomnia accompanied by depressive episodes / bipolar disorder, it can be found that didacinib is more effective in treating patients with insomnia accompanied by depressive episodes and patients with insomnia accompanied by depressive episodes / bipolar disorder, effectively reducing sleep-wake time and improving sleep quality.

[0335] Table 11 Analysis of the change in sleep awakenings (sNAW) from baseline on day 14 after baseline (FAS) in the sleep diary.

[0336] As shown in Table 11, didacinib helps reduce the number of sleep awakenings in insomnia patients (specifically including patients with primary insomnia, patients with insomnia accompanied by depressive episodes / bipolar disorder). Among them, comparing patients with primary insomnia and patients with insomnia accompanied by depressive episodes / bipolar disorder, it can be found that didacinib is more effective in treating patients with insomnia accompanied by depressive episodes and patients with insomnia accompanied by depressive episodes / bipolar disorder, effectively reducing the number of sleep awakenings and improving sleep quality.

[0337] Table 12 Analysis of the change in sleep efficiency (FASE) from baseline on day 14 after baseline (FAS) in sleep diaries

[0338] Table 12 shows that didacinib helps improve sleep efficiency in insomnia patients (specifically, patients with primary insomnia, and patients with insomnia accompanied by depressive episodes / bipolar disorder). Among them, comparing patients with primary insomnia and patients with insomnia accompanied by depressive episodes / bipolar disorder, it can be found that didacinib is more effective in treating patients with insomnia accompanied by depressive episodes and patients with insomnia accompanied by depressive episodes / bipolar disorder, and can effectively improve sleep efficiency and sleep quality.

[0339] Table 13 Analysis of the change in the total Insomnia Severity Index (ISI) score from baseline on day 14 after baseline (FAS) in the sleep diary

[0340] As shown in Table 13, didacinib helps alleviate the severity of insomnia in patients (specifically, patients with primary insomnia, patients with insomnia accompanied by depressive episodes / bipolar disorder depressive episodes, etc.).

[0341] Table 14 Analysis of changes in operational capability from baseline (FAS)

[0342] As shown in Table 14, didacinib helps improve the mobility of insomnia patients (specifically including patients with primary insomnia, patients with insomnia accompanied by depressive episodes / bipolar disorder depressive episodes, etc.).

[0343] Table 15 Analysis of the change in self-care score from baseline (FAS)

[0344] As shown in Table 15, didacinib helps improve the self-care ability of insomnia patients (specifically including patients with primary insomnia, patients with insomnia accompanied by depressive episodes / bipolar disorder depressive episodes, etc.).

[0345] Table 16 Analysis of changes in daily activity scores from baseline (FAS)

[0346] As shown in Table 16, didacinib helps improve the daily activities of insomnia patients (specifically including patients with primary insomnia, patients with insomnia accompanied by depressive episodes / bipolar disorder).

[0347] Table 17 Analysis of changes in pain or discomfort scores from baseline (FAS)

[0348] As shown in Table 17, didacinib helps relieve pain or discomfort in patients with insomnia (specifically, patients with primary insomnia, patients with insomnia accompanied by depressive episodes / bipolar disorder depressive episodes, etc.).

[0349] Table 18 Analysis of the change in anxiety or depression scores from baseline (FAS)

[0350] As shown in Table 18, didacinib helps alleviate anxiety or depression in insomnia patients (specifically including patients with primary insomnia, patients with insomnia accompanied by depressive episodes / bipolar disorder). Among them, comparing patients with primary insomnia and patients with insomnia accompanied by depressive episodes / bipolar disorder, it can be found that didacinib is more effective in treating patients with insomnia accompanied by depressive episodes and patients with insomnia accompanied by depressive episodes / bipolar disorder, and can effectively relieve anxiety or depression symptoms.

[0351] Table 19 Analysis of the change in health status score from baseline (FAS)

[0352] As shown in Table 19, didacinib helps improve the health status of insomnia patients (specifically including patients with primary insomnia, patients with insomnia accompanied by depressive episodes / bipolar disorder). Among them, comparing patients with primary insomnia and patients with insomnia accompanied by depressive episodes / bipolar disorder, it can be found that didacinib is more effective in treating patients with insomnia accompanied by depressive episodes and patients with insomnia accompanied by depressive episodes / bipolar disorder, and can effectively improve the health status of insomnia patients.

[0353] The embodiments of the present invention have been described above. However, the present invention is not limited to the above embodiments. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. Use of a didacinib, its prodrug, or a pharmaceutically acceptable salt thereof for the preparation of a medicament for the treatment of insomnia with or without mental or neurological disorders and / or insomnia with depressive episodes of mental or neurological disorders, or for the treatment of insomnia with or without mental or neurological disorders and / or insomnia with depressive episodes of mental or neurological disorders.

2. The use according to claim 1, wherein the didacinib, its prodrug, or a pharmaceutically acceptable salt thereof is used to prepare a medicament for increasing total sleep time in patients with insomnia accompanied by mental or neurological disorders or for increasing total sleep time in patients with insomnia accompanied by depressive episodes of mental or neurological disorders.

3. The use according to claim 1, wherein the didacinib, its prodrug, or a pharmaceutically acceptable salt thereof is used to prepare a medicament for reducing sleep latency in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia due to depressive episodes of mental or neurological disorders, or for reducing sleep latency in patients with insomnia accompanied by mental or neurological disorders and / or patients with insomnia due to depressive episodes of mental or neurological disorders.

4. The use according to claim 1, wherein the didacinib, its prodrug, or a pharmaceutically acceptable salt thereof is used to prepare a medicament for treating insomnia with depression, or for treating insomnia with depression.

5. The use according to claim 1, wherein the didacinib, its prodrug, or a pharmaceutically acceptable salt thereof is used to prepare a medicament for increasing total sleep time in patients with depression-related insomnia, or for increasing total sleep time in patients with depression-related insomnia.

6. The use according to claim 1, wherein the didacinib, its prodrug, or a pharmaceutically acceptable salt thereof is used to prepare a medicament for reducing sleep latency in patients with depression-associated insomnia, or for reducing sleep latency in patients with depression-associated insomnia.

7. The use according to claim 1, wherein the didacinib, its prodrug, or a pharmaceutically acceptable salt thereof is used to prepare a medicament for treating insomnia with depressive episodes, or for treating insomnia with depressive episodes.

8. The use according to claim 1, wherein the didacinib, its prodrug, or a pharmaceutically acceptable salt thereof is used to prepare a medicament for increasing total sleep time in patients with insomnia accompanied by depressive episodes, or for increasing total sleep time in patients with insomnia accompanied by depressive episodes.

9. The use according to claim 1, wherein the didacinib, its prodrug, or a pharmaceutically acceptable salt thereof is used to prepare a medicament for reducing sleep latency in patients with insomnia accompanied by depressive episodes, or for reducing sleep latency in patients with insomnia accompanied by depressive episodes.

10. The use according to claim 1, wherein the didacinib, its prodrug, or a pharmaceutically acceptable salt thereof is used to prepare a medicament for treating insomnia with bipolar disorder, or for treating insomnia with bipolar disorder.

11. The use according to claim 1, wherein the didacinib, its prodrug, or a pharmaceutically acceptable salt thereof is used to prepare a medicament for increasing total sleep time in patients with insomnia due to bipolar disorder, or for increasing total sleep time in patients with insomnia due to bipolar disorder.

12. The use according to claim 1, wherein the didacinib, its prodrug, or a pharmaceutically acceptable salt thereof is used to prepare a medicament for treating insomnia with bipolar disorder depressive episodes, or for treating insomnia with bipolar disorder depressive episodes.

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