Department of General Medicine, Kurashiki Central Hospital, 1-1-1 Miwa, Kurashiki, Okayama 710-8602, Japan.
Department of Gastroenterological Surgery, Cancer Institute Ariake Hospital, 3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan.
Sleep Med. 2014 Apr;15(4):385-92. doi: 10.1016/j.sleep.2013.11.788. Epub 2014 Feb 8.
Ramelteon is the first selective melatonin receptor agonist and currently is approved in the United States and Japan for the treatment of insomnia. Our meta-analysis assessed the efficacy and safety of ramelteon for the treatment of insomnia in adults. We included both published and unpublished data from randomized placebo-controlled trials evaluating the efficacy of ramelteon in adults with insomnia in the analysis. Our primary outcomes were sleep quality, subjective sleep latency (sSL), and subjective total sleep time (sTST). Secondary outcomes included latency to persistent sleep (LPS), total sleep time (TST), sleep efficiency (SE), proportion of rapid eye movement (REM) sleep, wakefulness after sleep onset (WASO), subjective WASO, number of nighttime awakenings (NAW), subjective NAW, and adverse events. Thirteen trials involving 5812 patients with insomnia or insomnia symptoms with a mean study duration of 38 days were pooled. Ramelteon was associated with reduced sSL (weighted mean difference [WMD], -4.30 min [95% confidence interval {CI}, -7.01 to -1.58]) and improved sleep quality (standardized mean differences, -0.074 [95% CI, -0.13 to -0.02]) but was not associated with increased sTST. Ramelteon also was associated with improvement in LPS, SE, and TST. The only significant adverse event was somnolence. Short-term use of ramelteon was associated with improvement in some sleep parameters in patients with insomnia, but its clinical impact is small. Long-term trials are needed before solid conclusions can be established.
雷美尔酮是首个选择性褪黑素受体激动剂，目前已获美国和日本批准用于治疗失眠症。本荟萃分析评估了雷美尔酮治疗成人失眠症的疗效和安全性。我们纳入了评估雷美尔酮治疗成人失眠症的随机安慰剂对照试验的已发表和未发表数据。我们的主要结局指标是睡眠质量、主观入睡潜伏期（sSL）和主观总睡眠时间（sTST）。次要结局指标包括入睡潜伏期（LPS）、总睡眠时间（TST）、睡眠效率（SE）、快速眼动（REM）睡眠时间比例、睡眠起始后觉醒时间（WASO）、主观 WASO、夜间觉醒次数（NAW）、主观 NAW 和不良事件。纳入了 13 项涉及 5812 例失眠或失眠症状患者的试验，平均研究持续时间为 38 天。雷美尔酮与缩短 sSL（加权均数差 [WMD]，-4.30 分钟 [95%置信区间 {CI}，-7.01 至 -1.58]）和改善睡眠质量（标准化均数差，-0.074 [95% CI，-0.13 至 -0.02]）有关，但与 sTST 增加无关。雷美尔酮还与 LPS、SE 和 TST 的改善有关。唯一显著的不良事件是嗜睡。短期使用雷美尔酮可改善失眠患者的一些睡眠参数，但临床影响较小。需要进行长期试验才能得出可靠的结论。
