Combinations of Eszopiclone and Trans 4-(3,4-Dichlorophenyl)-1,2,3,4-Tetrahydro-N-Methyl-1-Napthalenamine or Trans 4-(3,4-Dichlorophenyl)-1,2,3,4-Tetrahydro-1-Napthalenamine, and Methods of Treatment of Menopause and Mood, Anxiety, and Cognitive Disorders

Abstract

One aspect of the present invention relates to pharmaceutical compositions containing two or more active agents that when taken together can be used to treat, e.g., menopause, mood disorders, anxiety disorders, or cognitive disorders. The first component of the pharmaceutical composition is a sedative eszopiclone. The second component of the pharmaceutical composition is trans 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-napthalenamine or trans 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-1-napthalenamine. The present invention also relates to a method of treating menopause, perimenopause, mood disorders, anxiety disorders, and cognitive disorders.

Description

FIELD OF THE INVENTION[0001]The present invention relates to compositions and methods for the treatment of menopause and mood, anxiety, and cognitive disorders.BACKGROUND OF THE INVENTION[0002]Menopause, which is caused by a lowering of the production of female sex hormones that typically occurs at around age 50, but can occur at much earlier or later ages, can generate disorders such as edema, hot flushes (or flashes), attacks of sweating, muscle and possibly joint pain, sleep disturbances, dysphoria, nervousness, mood swings, headache, palpitations (enhanced frequency of heart rate), dry mucous membranes, pain during intercourse and urinary disturbances. Hot flashes or flushing are characterized by a sudden onset of warmth in the face and neck, often progressing to the chest. Episodes generally last several minutes and are evidenced by a visible flushing of the skin. Often such episodes are accompanied by sweating, dizziness, nausea, palpitations and diaphoresis. Such symptoms can...

AI Technical Summary

Benefits of technology

[0043]In addition, the present invention relates to a method for augmentation of antidepressant therapy in a patient comprising administering to the patient a therapeutically effective amount of eszopiclone, or a pharmaceutically acceptable salt, solvate, clathrate, polymorph, or co-crystal thereof. The present invention also relates to a method for eliciting a dose-sparing effect in a patient undergoing treatment with trans 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-napthalenamine or trans 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-1-napthalenamine comprising administering to the patient a therapeutically effective amount of eszopiclone, or a pharmaceutically acceptable salt, solvate, clathrate, polymorph, or co-crystal thereof.

Problems solved by technology

Often such episodes are accompanied by sweating, dizziness, nausea, palpitations and diaphoresis.

Such symptoms can disrupt sleep and interfere with quality of life.

The administration of female sex hormones, such as estrogen, is effective in palliating these symptoms, but hormone therapy is fraught with undesirable side effects.

The mood is typically depressed, irritable, and / or anxious.

The patient may appear miserable, with furrowed brows, downturned corners of the mouth, slumped posture, poor eye contact, and monosyllabic (or absent) speech.

The morbid mood may be accompanied by preoccupation with guilt, self-denigrating ideas, decreased ability to concentrate, indecisiveness, diminished interest in usual activities, social withdrawal, helplessness, hopelessness, and recurrent thoughts of death and suicide.

In some, the morbid mood is so deep that tears dry up; the patient complains of an inability to experience usual emotions—including grief, joy, and pleasure—and of a feeling that the world has become colorless, lifeless, and dead.

Sexual desire is often diminished or lost.

Anorexia and weight loss may lead to emaciation and secondary disturbances in electrolyte balance.

Unlike patients with melancholia, those with atypical depression show mood brightening to potentially positive events but often crash into a paralyzing depression with the slightest adversity.

In dysthymic disorder, depressive symptoms typically begin insidiously in childhood or adolescence and pursue an intermittent or low-grade course over many years or decades; major depressive episodes may complicate it (double depression).

It is a disorder in which an overwhelming traumatic event is reexperienced, causing intense fear, helplessness, horror, and avoidance of stimuli associated with the trauma.

The stressful event involves serious injury or threatened death to the person or others or actual death of others; during the event, the person experiences intense fear, helplessness, or horror.

Anxiety may be caused by use of drugs, such as alcohol, stimulants, caffeine, cocaine, and many prescription drugs.

Also, drug withdrawal is commonly associated with anxiety.

Dementia may occur at any age and can affect young people as the result of injury or hypoxia.

Cerebrovascular disease can destroy enough brain tissue to impair function.

Patients have prominent apathy and memory disturbances; they may show increased carelessness, poor personal hygiene, and decreased attention span.

Onset is usually insidious and occurs mostly in late middle or old age.

In most cases, evidence of precedent injury is lacking.

Normal-pressure hydrocephalus may result from scarring of arachnoid villi over convexities of the brain, which results in slowed absorption of CSF (ceresbrospinal fluid), ventricular dilatation, and frontal lobe motor abnormalities.

The results of treatment with CSF shunting are inconsistent.

However, some experts believe that after hematomas have exerted pressure on the brain for a long time (perhaps a year or more), removing them does little to improve cognitive function.

AIDS dementia can complicate the later stages of HIV infection.

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