[Translation] A multicenter, randomized, double-blind, placebo-controlled phase 3 clinical study to evaluate the efficacy and safety of lemborexant in the treatment of insomnia in Chinese subjects
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] Verify the efficacy and safety of lemborexant in the treatment of Chinese subjects with insomnia.
The main purpose is to verify using polysomnography (PSG) that lemborexant 10 mg (LEM10) is superior to placebo (PBO) in terms of objective sleep onset time assessed by persistent sleep latency (LPS) after 1 month of treatment in subjects with insomnia. Other purposes include comparing lemborexant 10 mg (LEM10) with placebo (PBO) in terms of sleep parameters (sleep onset time, sleep efficiency, wake-up time after sleep onset) after 1 month of treatment in subjects with insomnia. At the same time, evaluate the effect of lemborexant on the sleep of subjects with insomnia and its safety.