Orexin receptor antagonism for treatment of insomnia A randomized clinical trial of suvorexant
Orexin receptor antagonism for treatment of insomnia A randomized clinical trial of suvorexant
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DOI：
10.1212/wnl.0b013e31827688ee
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发表时间：
2012-12-01
期刊：
影响因子：
9.9
通讯作者：
Michelson, David
中科院分区：
文献类型：
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作者：
Herring, W. Joseph;Snyder, Ellen;Michelson, David
目的：评估食欲素受体拮抗剂作为治疗失眠的新方法的效用。方法：我们在一项随机、双盲、安慰剂对照、2 个周期（每个周期 4 周）交叉多导睡眠图研究中评估了 suvorexant（一种食欲素受体拮抗剂）治疗原发性失眠患者的效果。患者在一个时期接受suvorexant（10 mg [n = 62]、20 mg [n = 61]、40 mg [n = 59]或80 mg [n = 61]），另一期接受安慰剂（n = 249）。每个时期的第 1 晚和第 4 周结束时进行多导睡眠图检查。共同主要疗效终点是第 1 晚和第 4 周结束时的睡眠效率。次要终点是入睡后觉醒和持续睡眠潜伏期。结果：与安慰剂相比，Suvorexant 在第 1 晚和第 4 周结束时睡眠效率的共同主要终点上显示出显着（p 值 < 0.01）剂量相关的改善。还观察到睡眠诱导（持续睡眠潜伏期）和维持（入睡后觉醒）的剂量相关效应。 Suvorexant 总体耐受性良好。结论：数据表明，食欲素受体拮抗作用提供了一种治疗失眠的新方法。证据分类：本研究提供了 I 类证据，表明 suvorexant 在 4 周内改善了原发性失眠的非老年成年患者的睡眠效率。神经病学（R）2012；79：2265-2274
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. Neurology (R) 2012;79:2265-2274