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Combination of sedative and a neurotransmitter modulator, and methods for improving sleep quality and treating depression

a neurotransmitter and sleep quality technology, applied in the field of combination of sedatives and neurotransmitter modulators, and methods for improving sleep quality and treating depression, can solve the problems of limiting the usefulness of certain patient populations, high potential for addiction involving both physical and psychological dependence, and development of tolerance, so as to increase the effect of antidepressant therapy

Inactive Publication Date: 2005-08-11
SEPACOR INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, chronic use has been associated with a high potential for addiction involving both physical and psychological dependence.
However, many benzodiazepines possess side effects that limit their usefulness in certain patient populations.
These problems include synergy with other CNS depressants (especially alcohol), the development of tolerance upon repeat dosing, dependency, withdrawal, rebound insomnia following discontinuation of dosing, hangover effects the next day and impairment of psychomotor performance and memory.

Method used

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  • Combination of sedative and a neurotransmitter modulator, and methods for improving sleep quality and treating depression
  • Combination of sedative and a neurotransmitter modulator, and methods for improving sleep quality and treating depression
  • Combination of sedative and a neurotransmitter modulator, and methods for improving sleep quality and treating depression

Examples

Experimental program
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Effect test

example 1

[0852] Depression Response to Eszopiclone in Adults With Major Depressive Disorder (DREAMDD): A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 8-Week, Safety and Efficacy Study of Eszopiclone 3 mg Compared to Placebo in Subjects with Insomnia Related to Major Depressive Disorder

Rationale & Objectives

[0853] Insomnia often occurs simultaneously with the onset of major depression, and may negatively impact the depressed subject's quality of life (QoL) and functional abilities. In fact, in some patients, insomnia is the most disabling of the depressive symptom complex. In addition, many subjects are treated with selective serotonin re-uptake inhibitors (SSRIs) that may accentuate insomnia initially following treatment with these agents. This study aims to establish that the early addition of continuous eszopiclone 3 mg at bedtime to a standard antidepressant treatment with fluoxetine hydrochloride (20 or 40 mg) daily in the morning for 8 weeks is safe and provides impr...

example 2

Adjunctive Eszopiclone with Fluoxetine for MDD and Insomnia: Sleep Effects

[1159] Insomnia and depression often co-exist. This study evaluated the efficacy of eszopiclone for insomnia associated with MDD during concurrent fluoxetine treatment.

[1160] Methods: Patients (n=545) met DSM-IV criteria for MDD and insomnia, including reported sleep latency (SL)≧30 min (median 73 min), wake time after sleep onset (WASO)≧45 min (median 90 min), and total sleep time (TST)≦6.5 h (median 294 min). All patients received fluoxetine QAM, and were randomly assigned to double-blind treatment with eszopiclone 3 mg or placebo QHS for 8 weeks. Subjective sleep and daytime function were assessed weekly.

[1161] Results: Compared to placebo, eszopiclone was associated with significantly lower SL and greater TST at each treatment week (p<0.03); significantly lower WASO at Weeks 1, 3-5, and 7-8 (p<0.04); higher ratings across the treatment period in sleep quality and depth (p<0.005); and higher ratings of ...

example 3

Adjunctive Eszopiclone and Fluoxetine in MDD & Insomnia: Depression Effects

[1163] Insomnia frequently co-exists with depression. This study evaluated eszopiclone and fluoxetine co-administration in depressed patients with co-morbid insomnia.

[1164] Methods: Patients who met DSM-IV criteria for new MDD and insomnia received fluoxetine 20 mg QAM plus either eszopiclone 3 mg (n=275) or placebo (n=270) nightly for 8 weeks. Efficacy was assessed using HAMD17 and Clinical Global Impression Improvement (CGI-I) and Severity (CGI-S). Response=50% decrease from baseline HAMD17; remission=HAMD17≦7.

[1165] Results: Eszopiclone co-administration resulted in significantly greater changes in HAMD17 scores at Week 4 (−9.9 vs −8.5 for placebo, p=0.02) with progressive improvement at Week 8 (−13.8 vs −11.8, p<0.001). At Week 8, significantly more eszopiclone patients were responders (74% vs 61%, p<0.009) and remitters (54% vs 41%, p<0.02). Even with removal of insomnia items, significant difference...

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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., insomnia and / or depression. The first component of the pharmaceutical composition is a GABA receptor modulating compound. The second component of the pharmaceutical composition is a serotonin reuptake inhibitor, a norepinephrine reuptake inhibitor, a 5-HT2A modulator, or dopamine reuptake inhibitor. In certain embodiments, the pharmaceutical composition comprises eszopiclone. In a preferred embodiment, the pharmaceutical composition comprises eszopiclone and fluoxetine. The present invention also relates to a method of treating a sleep abnormality, treating insomnia, treating depression, augmenting antidepressant therapy, eliciting a dose-sparing effect, reducing depression relapse, improving the efficacy of antidepressant therapy or improving the tolerability of antidepressant therapy, comprising co-administering to a patient in need thereof a GABA-receptor-modulating compound; and a SRI, NRI, 5-HT2A modulator or DRI.

Description

RELATED APPLICATIONS [0001] This application claims the benefit of priority to U.S. Provisional Patent Application Ser. No. 60 / 529,156, filed Dec. 11, 2003; and U.S. Provisional Patent Application Ser. No. 60 / 541,614, filed Feb. 4, 2004; and U.S. Provisional Patent Application Ser. No. 60 / ______, filed Dec. 3, 2004; the specifications of each application are hereby incorporated by reference.BACKGROUND OF THE INVENTION [0002] Sleep is controlled by two biological processes, the homeostatic drive and the circadian rythym. The homestatic drive manifests itself as an increased drive for sleep. This drive for sleep accumulates across the period of wakefulness (typically daytime) and dissipates across the sleep period. The circadian rhythm of sleep-wake shows a biphasic curve with the greatest drive for sleep occurring between midnight and 5 AM, and between 2 PM and 4 PM. It is believed that major circadian influences are an alerting pulse in the evening and in the morning. It is the inte...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/137A61K31/138A61K31/495A61K31/4985A61K31/724A61K45/06
CPCA61K31/137A61K31/138A61K31/495A61K31/4985A61K31/724A61K45/06A61K2300/00A61P25/20A61P25/24A61P43/00
Inventor LALJI, KARIMBARBERICH, TIMOTHY J.CARON, JUDYWESSEL, THOMAS
Owner SEPACOR INC
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