Neurology：促食素受体拮抗剂可以用来治疗失眠

为了评估促食素受体拮抗剂能否作为一种新的治疗失眠的方法。美国迈阿密底特律的亨利福特医院睡眠中心和Merck Sharp & Dohme公司合作进行了一项研究，研究结果在线发表在2012年11月28日的Neurology杂志上。研究结果显示：促食素受体拮抗剂能够成为一种新的失眠治疗方法。

该研究是一项随机、双盲、安慰剂对照、双期、交叉多导睡眠图研究。研究中评估suvorexant（一种促食素受体拮抗剂）治疗原发性失眠的的效果。在一个时期，患者接受suvorexant(10 mg [n = 62], 20 mg [n = 61], 40 mg [n = 59],或80 mg [n = 61])，在另一个时期接受安慰剂治疗。每个时期均在服药后第一个晚上和服药后4周末进行多导睡眠图检查。共同的主要终点是服药后第一个晚上的睡眠效果和服药后4周末的睡眠效果。次要的终点是入睡后苏醒和潜伏期到持续睡眠。

研究结果显示：在服药后第一夜和服药后4周末睡眠效果作为共同的主要终点，suvorexant对比安慰剂显示出剂量相关的改善效果。剂量相关效果在睡眠诱导（潜伏期进行持续睡眠期）和睡眠维持（入睡后到苏醒）阶段也存在。suvorexant大都能够很好地耐受。

该研究显示：研究结果显示促食素受体拮抗剂提供了一种新的治疗失眠的方法.

与失眠相关的拓展阅读： 

• Sci Transl Med：潜在抗失眠新药DORA-22副作用极低
• Eur Heart J：失眠者发生心衰风险高
• Neurology：拮抗食欲素受体 或成为治疗失眠新机制
• SLEEP：褪黑素可改善高血压患者应用β受体阻滞剂相关失眠
• 认知行为疗法治疗失眠症患者 更多信息请点击：有关失眠更多资讯

Orexin receptor antagonism for treatment of insomnia A randomized clinical trial of suvorexant
Objective
To assess the utility of orexin receptor antagonism as a novel approach to treating insomnia.
Methods
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.
Results
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.
Conclusions
The data suggest that orexin receptor antagonism offers a novel approach to treating insomnia. Classification of evidence: This study provides Class I evidence that suvorexant improves sleep efficiency over 4 weeks in nonelderly adult patients with primary insomnia. Glossary DSM-IV-TR= Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision; DSCT= Digit Symbol Copying Test; DSST= Digit Symbol Substitution Test; LPS= latency to persistent sleep; PSG= polysomnography; SE= sleep efficiency; sTSO= subjective time to sleep onset; sTST= subjective total sleep time; TST= total sleep time; WASO= wake after sleep onset