Department of Neuropsychiatry, Kurume University School of Medicine, Kurume, Japan.
Expert Rev Neurother. 2011 Feb;11(2):215-24. doi: 10.1586/ern.10.197.
This randomized, double-blind, placebo-controlled study assessed the efficacy and safety of ramelteon 4 and 8 mg in Japanese adults with chronic insomnia. A secondary objective was to evaluate efficacy and safety when doses were uptitrated from placebo, ramelteon 4 and 8 mg to 4, 8 and 16 mg, respectively. Patient-reported sleep data were collected using sleep diaries. There was no statistically significant difference between ramelteon and placebo in the change in subjective sleep latency (sSL) in the full analysis set (n = 1130). Significant improvement was observed in the change in subjective total sleep time with ramelteon 8 mg at week 1. In post hoc analyses, ramelteon 8 mg reduced sSL in individuals with smaller fluctuations (within ±30 min) of sSL at baseline, in those with a shorter (<1 year) history of insomnia and in individuals who had not used benzodiazepines. Ramelteon up to 16 mg nightly was safe and well tolerated.
这项随机、双盲、安慰剂对照研究评估了雷美替胺 4 毫克和 8 毫克在慢性失眠的日本成年患者中的疗效和安全性。次要目标是评估从安慰剂、雷美替胺 4 毫克和 8 毫克分别递增剂量至 4 毫克、8 毫克和 16 毫克时的疗效和安全性。使用睡眠日记收集患者报告的睡眠数据。在全分析集（n = 1130）中，雷美替胺与安慰剂相比，主观睡眠潜伏期（sSL）的变化无统计学差异。在第 1 周观察到雷美替胺 8 毫克对主观总睡眠时间的变化有显著改善。事后分析显示，雷美替胺 8 毫克可减少 sSL 波动较小（±30 分钟内）的个体的 sSL，减少失眠病史较短（<1 年）的个体和未使用苯二氮䓬类药物的个体的 sSL。每晚使用雷美替胺 16 毫克是安全且耐受良好的。
