Broadhurst A, Cushnaghan R C
West Suffolk Hospital, Bury Saint Edmunds, U.K.
Sleep. 1987;10 Suppl 1:48-53.
A double-blind, randomized, cross-over study has been conducted with zopiclone (Imovane), a new cyclopyrrolone hypnotic in ten healthy volunteers. Hypnotic efficacy has previously been demonstrated at a dose of 7.5 mg. The present study was designed to determine the overnight residual effects of different doses of the drug ranging from 2.5 to 10 mg. Measurement of complex reaction time was used as an objective test of impairment of psychomotor function. To supplement this, the volunteers were asked to report, by means of visual analogue scales, any perceived changes in their performance in the complex reaction time test, in their mood, and in the onset and quality of sleep. Complex reaction time testing revealed no significant impairment except at 12 h after the 10 mg dose. Subjective assessments of onset of sleep showed a dose-dependent shortening of sleep latency, confirming the hypnotic action of the drug. Volunteers were aware of a decline in psychomotor performance, of some sleepiness on awakening, and decreased alertness after previous night doses of 7.5 and 10 mg. It is concluded that a dose of 7.5 mg is optimal, producing significant hypnotic effect with minimal residual impairment.
对10名健康志愿者进行了一项双盲、随机、交叉研究，研究对象为新型环吡咯酮类催眠药佐匹克隆（忆梦返）。先前已证明7.5毫克剂量的催眠效果。本研究旨在确定2.5至10毫克不同剂量药物的过夜残留效应。将复合反应时间的测量用作心理运动功能受损的客观测试。作为补充，要求志愿者通过视觉模拟量表报告他们在复合反应时间测试中的表现、情绪以及睡眠开始和质量方面的任何感知变化。复合反应时间测试显示，除10毫克剂量后12小时外，无明显损伤。对睡眠开始的主观评估显示睡眠潜伏期呈剂量依赖性缩短，证实了该药物的催眠作用。志愿者意识到心理运动表现下降、醒来时有些困倦，以及前一晚服用7.5毫克和10毫克剂量后警觉性降低。得出结论，7.5毫克的剂量是最佳的，能产生显著的催眠效果且残留损伤最小。
