Surrey Clinical Research Centre, University of Surrey, Guildford, Surrey, UK.
J Clin Psychopharmacol. 2012 Oct;32(5):704-9. doi: 10.1097/JCP.0b013e3182664eec.
Next-day residual effects of single evening doses of 3 mg of eszopiclone, 7.5 mg of zopiclone, and placebo were assessed in a randomized, double-blind, placebo-controlled, 3-way crossover study that used a mild sleep restriction protocol (sleep duration, 7 hours). During each period, 91 healthy volunteers spent 2 consecutive nights in the laboratory with time in bed restricted to 7 hours. Volunteers completed the Continuous Tracking Test, Critical Flicker Fusion task, Digit Symbol Substitution Test, N-back tasks, and Linear Analogue Rating Scales every half-hour from 7.5 to 11.5 hours after dose, commencing 15 minutes after awakening. Nighttime dosing of both eszopiclone (3 mg) and racemic zopiclone (7.5 mg) was associated with next-day performance impairment, and these residual effects dissipated over time. Eszopiclone did not differ from zopiclone on the primary end point, mean Continuous Tracking Test tracking error averaged from 7.5 to 9.5 hours after dose; however, a prespecified post hoc parametric analysis of reciprocal-transformed data favored eszopiclone over racemic zopiclone (P = 0.026).
一项随机、双盲、安慰剂对照的 3 向交叉研究评估了单剂量 3 毫克艾司佐匹克隆、7.5 毫克佐匹克隆和安慰剂在次日的残留效应,该研究采用了轻度睡眠限制方案(睡眠时间 7 小时)。在每个时期,91 名健康志愿者在实验室中连续度过 2 个晚上,卧床时间限制为 7 小时。志愿者在给药后 7.5 至 11.5 小时每半小时完成连续跟踪测试、临界闪烁融合任务、数字符号替代测试、N-back 任务和线性模拟评分量表,在唤醒后 15 分钟开始。夜间给予艾司佐匹克隆(3 毫克)和消旋佐匹克隆(7.5 毫克)均与次日的表现受损有关,这些残留效应随时间消散。在主要终点上,艾司佐匹克隆与佐匹克隆无差异,即从给药后 7.5 至 9.5 小时的平均连续跟踪测试跟踪误差;然而,对转换后数据的预设事后参数分析有利于艾司佐匹克隆优于消旋佐匹克隆(P = 0.026)。