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

作者：Uchimura Naohisa^*; Kamijo Atsushi; Kuwahara Hiroo; Uchiyama Makoto; Shimizu Tetsuo; Chiba Shigeru; Inoue Yuichi

来源：Sleep Medicine, 2012, 13(10): 1247-1253.

DOI：10.1016/j.sleep.2012.08.015

• Eszopiclone
• Primary insomnia
• Japanese
• Polysomnography
• Sleep latency
• WASO

Objectives: To evaluate the efficacy and dose-response effect of eszopiclone on sleep latency and sleep maintenance in Japanese patients with primary insomnia. %26lt;br%26gt;Methods: In this randomized, double-blind, five-way crossover study, 72 patients received placebo, eszopiclone 1 mg, 2 mg, and 3 mg, and zolpidem 10 mg 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. %26lt;br%26gt;Results: All active treatments produced significant improvement in objective and subjective sleep latency compared with placebo (P %26lt; 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 2 mg and 3 mg and zolpidem 10 mg versus placebo (P %26lt; 0.05). Eszopiclone at all doses increased total sleep time and stage 2 sleep time (P %26lt; 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. %26lt;br%26gt;Conclusions: In Japanese patients with primary insomnia, eszopiclone 2 mg and 3 mg significantly improved PSG-determined and patient-reported sleep latency and sleep maintenance relative to placebo.

• 出版日期2012-12