Takeda Pharmaceuticals International, Deerfield, IL, USA.
Sleep Med. 2011 Oct;12(9):920-3. doi: 10.1016/j.sleep.2011.06.008. Epub 2011 Sep 16.
Ramelteon is an MT(1)/MT(2) melatonin receptor agonist approved in the US and Japan for the treatment of sleep-onset insomnia. This study evaluated the effects of ramelteon 8mg on patient reported sleep parameters in adults with chronic insomnia in an at-home setting using a post-sleep questionnaire-interactive voice response system (PSQ-IVRS).
Adults aged 18-64 years with chronic insomnia were randomized to receive ramelteon 8 mg or placebo nightly for 3weeks. Sleep parameters were assessed via PSQ-IVRS within 60 min of awakening each morning. Adverse effects were collected throughout the study.
A total of 552 subjects (mean age 43.2 years) received treatment (274 ramelteon, 278 placebo). There was a reduction in mean sleep latency at weeks 1, 2, and 3 compared with placebo but none reached statistical significance (-4.1 min, p=0.088 week 1; -2.8 min, p=0.258 week 2; -4.9 min, p=0.060 week 3). There were no significant differences between placebo and ramelteon in other PSQ-IVRS sleep parameters. Only headache (18 [6.5%] placebo, 18 [6.6%] ramelteon) and somnolence (5 [1.8%], 12 [4.4%] ramelteon) occurred in>3% of subjects.
Use of ramelteon 8 mg in an at-home setting did not demonstrate statistically significant improvements in subjective sleep latency compared with placebo, when measured by PSQ-IVRS.
雷美替胺是一种 MT（1）/MT（2）褪黑素受体激动剂，已获美国和日本批准用于治疗入睡困难型失眠症。本研究采用睡眠后问卷-交互式语音应答系统（PSQ-IVRS），评估雷美替胺 8mg 对在家中治疗慢性失眠成人患者报告的睡眠参数的影响。
年龄在 18-64 岁的慢性失眠成人患者被随机分为每晚接受雷美替胺 8mg 或安慰剂治疗 3 周。每天早晨醒来后 60 分钟内通过 PSQ-IVRS 评估睡眠参数。在整个研究过程中收集不良反应。
共有 552 名受试者（平均年龄 43.2 岁）接受了治疗（雷美替胺 274 名，安慰剂 278 名）。与安慰剂相比，第 1、2 和 3 周的平均入睡潜伏期均有缩短，但均无统计学意义（-4.1min，p=0.088 第 1 周；-2.8min，p=0.258 第 2 周；-4.9min，p=0.060 第 3 周）。PSQ-IVRS 的其他睡眠参数中，安慰剂和雷美替胺之间无显著差异。仅头痛（安慰剂 18 例[6.5%]，雷美替胺 18 例[6.6%]）和嗜睡（安慰剂 5 例[1.8%]，雷美替胺 12 例[4.4%]）在>3%的受试者中发生。
在家中使用雷美替胺 8mg 与安慰剂相比，通过 PSQ-IVRS 测量，并未显示在主观入睡潜伏期方面有统计学意义的改善。
