Kishi Taro, Matsunaga Shinji, Iwata Nakao
Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.
PLoS One. 2015 Aug 28;10(8):e0136910. doi: 10.1371/journal.pone.0136910. eCollection 2015.
We performed a systematic review and meta-analysis of double-blind, randomized, placebo-controlled trials evaluating suvorexant for primary insomnia.
Relevant studies were identified through searches of PubMed, databases of the Cochrane Library, and PsycINFO citations through June 27, 2015. We performed a systematic review and meta-analysis of suvorexant trial efficacy and safety outcomes. The primary efficacy outcomes were either subjective total sleep time (sTST) or subjective time-to-sleep onset (sTSO) at 1 month. The secondary outcomes were other efficacy outcomes, discontinuation rate, and individual adverse events. The risk ratio, number-needed-to-treat/harm, and weighted mean difference (WMD) and 95% confidence intervals (CI) based on a random effects model were calculated.
The computerized literature database search initially yielded 48 results, from which 37 articles were excluded following a review of titles and abstracts and another eight review articles after full-text review. Thus, we identified 4 trials that included a total of 3,076 patients. Suvorexant was superior to placebo with regard to the two primary efficacy outcomes (sTST: WMD = -20.16, 95% CI = -25.01 to -15.30, 1889 patients, 3 trials, sTSO: WMD = -7.62, 95% CI = -11.03 to -4.21, 1889 patients, 3 trials) and was not different from placebo in trial discontinuations. Suvorexant caused a higher incidence than placebo of at least one side effects, abnormal dreams, somnolence, excessive daytime sleepiness/sedation, fatigue, dry mouth, and rebound insomnia.
Our analysis of published trial results suggests that suvorexant is effective in treating primary insomnia and is well-tolerated.
我们对评估苏沃雷生治疗原发性失眠的双盲、随机、安慰剂对照试验进行了系统评价和荟萃分析。
通过检索PubMed、Cochrane图书馆数据库以及截至2015年6月27日的PsycINFO引文来确定相关研究。我们对苏沃雷生试验的疗效和安全性结果进行了系统评价和荟萃分析。主要疗效结果为1个月时的主观总睡眠时间（sTST）或主观入睡时间（sTSO）。次要结果为其他疗效结果、停药率和个体不良事件。计算基于随机效应模型的风险比、需治疗人数/危害人数、加权平均差（WMD）和95%置信区间（CI）。
计算机化文献数据库搜索最初得到48个结果，在对标题和摘要进行审查后排除了37篇文章，在全文审查后又排除了8篇综述文章。因此，我们确定了4项试验，共纳入3076例患者。在两项主要疗效结果方面，苏沃雷生优于安慰剂（sTST：WMD = -20.16，95%CI = -25.01至-15.30，1889例患者，3项试验；sTSO：WMD = -7.62，95%CI = -11.03至-4.21，1889例患者，3项试验），在试验停药方面与安慰剂无差异。苏沃雷生导致至少一种副作用的发生率高于安慰剂，包括异常梦境、嗜睡、日间过度嗜睡/镇静、疲劳、口干和反弹性失眠。
我们对已发表试验结果的分析表明，苏沃雷生治疗原发性失眠有效且耐受性良好。
