Merck Sharp & Dohme Corp., Whitehouse Station, NJ, USA.
Neurology. 2012 Dec 4;79(23):2265-74. doi: 10.1212/WNL.0b013e31827688ee. Epub 2012 Nov 28.
To assess the utility of orexin receptor antagonism as a novel approach to treating insomnia.
We evaluated suvorexant, an orexin receptor antagonist, for treating patients with primary insomnia in a randomized, double-blind, placebo-controlled, 2-period (4 weeks per period) crossover polysomnography study. Patients received suvorexant (10 mg [n = 62], 20 mg [n = 61], 40 mg [n = 59], or 80 mg [n = 61]) in one period and placebo (n = 249) in the other. Polysomnography was performed on night 1 and at the end of week 4 of each period. The coprimary efficacy end points were sleep efficiency on night 1 and end of week 4. Secondary end points were wake after sleep onset and latency to persistent sleep.
Suvorexant showed significant (p values <0.01) dose-related improvements vs placebo on the coprimary end points of sleep efficiency at night 1 and end of week 4. Dose-related effects were also observed for sleep induction (latency to persistent sleep) and maintenance (wake after sleep onset). Suvorexant was generally well tolerated.
The data suggest that orexin receptor antagonism offers a novel approach to treating insomnia.
This study provides Class I evidence that suvorexant improves sleep efficiency over 4 weeks in nonelderly adult patients with primary insomnia.
评估食欲素受体拮抗剂作为治疗失眠的新方法的效用。
我们评估了苏沃雷生（一种食欲素受体拮抗剂）在一项随机、双盲、安慰剂对照、2 期（每周期 4 周）交叉多导睡眠图研究中治疗原发性失眠患者的效果。患者在一个周期内接受苏沃雷生（10mg[n=62]、20mg[n=61]、40mg[n=59]或 80mg[n=61]）治疗，在另一个周期内接受安慰剂（n=249）治疗。每个周期的第 1 天和第 4 周末进行多导睡眠图检查。主要疗效终点为第 1 天和第 4 周末的睡眠效率。次要终点为睡眠起始后的觉醒和持续睡眠潜伏期。
苏沃雷生与安慰剂相比，在第 1 天和第 4 周末的主要疗效终点睡眠效率上具有显著的（p 值<0.01）剂量相关性改善。在睡眠诱导（持续睡眠潜伏期）和维持（睡眠后觉醒）方面也观察到了剂量相关的效果。苏沃雷生通常具有良好的耐受性。
数据表明，食欲素受体拮抗剂为治疗失眠提供了一种新方法。
这项研究提供了 I 级证据，表明苏沃雷生可改善非老年原发性失眠患者 4 周的睡眠效率。
