[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase 3 study to evaluate the efficacy and safety of lemborexant in Chinese subjects with insomnia disorder
验证Lemborexant治疗中国失眠障碍受试者的疗效和安全性。
其中主要目的是使用多导睡眠监测(PSG)验证,在失眠障碍受试者接受治疗1个月后,通过持续入睡潜伏期(LPS)评估客观入睡时间,lemborexant 10 mg(LEM10)优于安慰剂(PBO)。其他目的包括在失眠障碍受试者接受治疗1个月后,通过睡眠参数(入睡时间,睡眠效率,入睡后觉醒时间)评估,lemborexant 10 mg(LEM10)与安慰剂(PBO)的对比。同时评估Lemborexant对失眠障碍受试者睡眠的影响以及安全性。
[Translation] To verify the efficacy and safety of Lemborexant in Chinese subjects with insomnia disorder.
The primary objective was to use polysomnography (PSG) to validate that lemborexant 10 mg (LEM10) was superior to placebo ( PBO). Additional objectives included lemborexant 10 mg (LEM10) versus placebo (PBO) as assessed by sleep parameters (time to fall asleep, sleep efficiency, time to wake after sleep onset) in subjects with insomnia disorder after 1 month of treatment. The effects and safety of Lemborexant on sleep in subjects with insomnia disorders were also evaluated.