A randomized placebo-controlled polysomnographic study of eszopiclone in Japanese patients with primary insomnia.

Abstract

OBJECTIVES:

To evaluate the efficacy and dose-response effect of eszopiclone on sleep latency and sleep maintenance in Japanese patients with primary insomnia.

METHODS:

In this randomized, double-blind, five-way crossover study, 72 patients received placebo, eszopiclone 1mg, 2mg, and 3mg, and zolpidem 10mg in random order for two consecutive nights with a washout period between treatments. Objective sleep measures from polysomnography (PSG) and subjective patient reports were collected.

RESULTS:

All active treatments produced significant improvement in objective and subjective sleep latency compared with placebo (P<0.05 for all comparisons); linear dose-response relationships were observed for eszopiclone. PSG-determined wake time after sleep onset (WASO), sleep efficiency, and number of awakenings (NA), and patient-reported measures of WASO, NA, sleep quality, sleep depth, and daytime functioning significantly improved following treatment with eszopiclone 2mg and 3mg and zolpidem 10mg versus placebo (P<0.05). Eszopiclone at all doses increased total sleep time and stage 2 sleep time (P<0.001 for both comparisons), but did not alter REM or slow-wave sleep. Eszopiclone was generally well tolerated; the most frequently reported adverse event was mild dysgeusia.

CONCLUSIONS:

In Japanese patients with primary insomnia, eszopiclone 2mg and 3mg significantly improved PSG-determined and patient-reported sleep latency and sleep maintenance relative to placebo.

• Authors: Naohisa Uchimura, Atsushi Kamijo, Hiroo Kuwahara, Makoto Uchiyama, Tetsuo Shimizu, Shigeru Chiba, Yuichi Inoue
• Journal: Sleep medicine (Sleep Med) Vol. 13 Issue 10 Pg. 1247-53 (Dec 2012) ISSN: 1878-5506 [Electronic] Netherlands
• PMID: 23063301 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2012 Elsevier B.V. All rights reserved.

Chemical References

• Azabicyclo Compounds
• Hypnotics and Sedatives
• Piperazines
• Eszopiclone

Topics

• Adult
• Azabicyclo Compounds (adverse effects, therapeutic use)
• Cross-Over Studies
• Dose-Response Relationship, Drug
• Double-Blind Method
• Eszopiclone
• Female
• Humans
• Hypnotics and Sedatives (adverse effects, therapeutic use)
• Japan
• Male
• Middle Aged
• Piperazines (adverse effects, therapeutic use)
• Polysomnography
• Sleep Initiation and Maintenance Disorders (drug therapy, physiopathology)
• Young Adult