Over-the-Counter Agents for the Treatment of Occasional Disturbed Sleep or Transient Insomnia: A Systematic Review of Efficacy and Safety.
Over-the-Counter Agents for the Treatment of Occasional Disturbed Sleep or Transient Insomnia: A Systematic Review of Efficacy and Safety.
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DOI：
10.4088/pcc.15r01798
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发表时间：
2015-01-01
影响因子：
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通讯作者：
Wingertzahn, Mark A
中科院分区：
文献类型：
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作者：
Culpepper, Larry;Wingertzahn, Mark A
目的：调查支持使用常见非处方（OTC）药物的证据水平（苯海拉明，多西拉敏，褪黑激素，和缬）偶尔干扰睡眠或失眠。数据来源：2014年7月31日对文献进行了系统综述，使用MEDLINE（PubMed）和检索词（失眠或睡眠）和（非处方药或OTC或非处方药或抗组胺药或多西拉敏或苯海拉明或褪黑激素或缬草），带过滤器英国人，人，研究选择：选择符合纳入标准的已识别出版物（从2003年至2014年7月31日，遵循先前发表的文献综述）。标准包括随机安慰剂对照临床研究，采用过夜客观（多导睡眠描记）或第二天参与者报告的睡眠相关终点，并在有或没有偶尔的睡眠障碍或诊断的失眠症的健康参与者中进行。H1拮抗剂或抗组胺药（3项研究，苯海拉明）、褪黑激素（8）和缬或缬/啤酒花（7）。在3种睡眠药物中，使用褪黑激素进行的研究，特别是在诊断为失眠的老年人中使用的缓释制剂，证明了对睡眠指标（特别是睡眠开始和睡眠质量）最一致的有益作用（与安慰剂相比），具有良好的耐受性。与此相反，苯海拉明，立即释放褪黑激素，和缬草的临床试验数据建议有限的有益effics.CONCLUSIONS：回顾随机对照研究在过去的12年中表明，常用的OTC睡眠援助剂，特别是苯海拉明和缬草，缺乏强大的临床证据支持的疗效和安全性。
OBJECTIVE: To investigate the level of evidence supporting the use of common over-the-counter (OTC) agents (diphenhydramine, doxylamine, melatonin, and valerian) for occasional disturbed sleep or insomnia.DATA SOURCES: A systematic review of the literature was conducted on July 31, 2014, using MEDLINE (PubMed) and the search terms (insomnia OR sleep) AND (over*the*counter OR OTC OR non*prescription OR antihistamine OR doxylamine OR diphenhydramine OR melatonin OR valerian) with the filters English, human, and clinical trials.STUDY SELECTION: Identified publications (from 2003 to July 31, 2014, following previous published literature reviews) that met the inclusion criteria were selected. The criteria included randomized placebo-controlled clinical studies that utilized overnight objective (polysomnography) or next-day participant-reported sleep-related endpoints and that were conducted in healthy participants with or without occasional disturbed sleep or diagnosed insomnia.RESULTS: Measures of efficacy and tolerability were summarized for each study individually and grouped according to OTC agent: H1 antagonists or antihistamines (3 studies, diphenhydramine), melatonin (8), and valerian or valerian/hops (7). Of the 3 sleep agents, studies conducted with melatonin, especially prolonged-release formulations in older individuals with diagnosed insomnia, demonstrated the most consistent beneficial effects (vs placebo) on sleep measures, specifically sleep onset and sleep quality, with favorable tolerability. In contrast, the clinical trial data for diphenhydramine, immediate-release melatonin, and valerian suggested limited beneficial effects.CONCLUSIONS: A review of randomized controlled studies over the past 12 years suggests commonly used OTC sleep-aid agents, especially diphenhydamine and valerian, lack robust clinical evidence supporting efficacy and safety.