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Method for treating primary insomnia

A therapeutic agent, melatonin technology, applied in the direction of pharmaceutical formulations, organic active ingredients, non-central analgesics, etc., can solve the problems of improvement, inability to distinguish the time of active melatonin treatment, and failure to report the quantity or quality of sleep

Inactive Publication Date: 2004-10-27
NEURIM PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Ellis, C.M., et al. in J. Sleep Res., 1996, 5: 61-65: Melatonin (5 mg) administered at 8:00 pm for one week to psychophysiological insomnia patients did not report sleep quantity or quality improved; in 8 of 15 patients, the timing of active melatonin treatment could not be discerned

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] method: Taking 40 elderly patients with primary insomnia (aged 76 [SD8] years) as the research object, according to the randomized double-blind research method of the parallel control group, the effect of extended-release preparations of melatonin on sleep quality and sleep quantity was studied. Subjects were treated with melatonin (2 mg extended release formulation) or placebo every evening for 3 weeks. During the last two days of treatment, overnight polysomnographic recordings of the subjects were performed. Every night after sleep recordings in the laboratory, all patients underwent a battery of psychomotor tests to assess daytime vigilance. In addition, patients recorded daily in a diary how they felt about the quality of their sleep from the previous night.

[0035] result: Compared with the placebo-treated group, the melatonin-treated group significantly improved sleep induction (as measured by sleep latency (SL)), time awake before sleep onset (DWAPSO), and...

Embodiment 2

[0039] method .Taking 170 elderly patients with primary insomnia (age 68.5 [SD8.3] years old) as the research object, according to the randomized double-blind research method of the parallel control group, the extended-release preparation of melatonin was studied for the subjective evaluation of sleep quality and The role of vigilance during the day. Subjects were treated with placebo for 2 weeks to establish baseline characteristics, and then treated with melatonin (2 mg extended release formulation / night) or placebo for 3 weeks. During the baseline period and the last 3 days of the treatment period, patients were asked about the quality of their sleep the previous night and how they were feeling that morning. Among them, the sleep quality question is "How do you compare the sleep quality of medication and the sleep quality of no medication (usually)?" On the 100mm long non-hatched horizontal line with two endpoints, let the patient mark the sleep he feels quality. The le...

Embodiment 3

[0045]METHODS: According to the parallel controlled randomized double-blind study method, in 131 patients with primary insomnia (age 20-80 years old), the effects of melatonin on sleep quality and daytime vigilance were subjectively evaluated. Subjects were treated with placebo for 1 week to establish baseline characteristics, followed by 3 weeks of melatonin or placebo (2 mg / night extended release formulation). At baseline and on the last three days of the treatment period, patients were interviewed as described in Example 2 to assess the quality of their sleep the previous night and how they felt that day.

[0046] Results: In patients 55 years of age or older, sleep quality and daytime alertness were improved compared to other studies of elderly patients (see Example 2). Surprisingly, sleep quality and daytime alertness were significantly worse in patients younger than 55 years compared with placebo. The results are shown in Table 2.

[0047] reaction

[0048] ...

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PUM

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Abstract

The invention relates to a medicament, for treating and improving the restorative quality of sleep, in a patient suffering from primary insomnia, which comprises at least one compound selected from melatonin, other melatonergic agents, melatonin agonists and melatonin antagonists, in an effective amount within the range of 0.0025 to 50 mg, and optionally one or more other therapeutically active agents.

Description

field of invention [0001] The present invention relates to the method for treating primary insomnia (defined by DSM-IV, or non-organic insomnia defined by ICD-10) characterized by non-restorative sleep; The present invention also relates to Use of melatonin or certain other compounds for the preparation of a medicament for the aforementioned therapeutic purposes; the invention also relates to a medicament comprising a combination of compounds for improving the quantity and quality of sleep in patients with primary insomnia. Background of the invention [0002] Sleep disorders are a complex disease, especially widespread in Western industrialized countries. It is estimated that about one-third of adults report at least occasional sleep difficulties, and at least half of the sleep-disordered population complains of sleeping for several years. US 5,776,969 (James) discloses a method of treatment of various sleep disorders using specific combinations of compounds, where primary...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/32A61K9/20A61K31/4045A61K45/00A61K45/08A61P3/04A61P9/12A61P25/04A61P25/18A61P25/20A61P25/22A61P25/24A61P29/00
CPCA61K31/4045A61K9/2009A61K9/2027A61P25/00A61P25/04A61P25/18A61P25/20A61P25/22A61P25/24A61P29/00A61P3/04A61P43/00A61P9/12
Inventor 纳瓦·齐萨佩尔
Owner NEURIM PHARMA
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