Roth T, Roehrs T, Vogel G
Sleep Disorders and Research Center, Henry Ford Hospital, Detroit, Michigan 48202, USA.
Sleep. 1995 May;18(4):246-51. doi: 10.1093/sleep/18.4.246.
Transient insomnia may be induced by stress, sleep in unfamiliar surroundings, jet lag and other factors. Zolpidem, a novel imidazopyridine hypnotic, has been shown to have hypnotic properties in most patients without significantly affecting next-day performance. Using the first-night effect in a sleep laboratory as a model of transient insomnia, this placebo-controlled, double-blind, parallel-group study evaluated the efficacy and safety of zolpidem in 462 normal volunteers. Zolpidem was tested at doses of 5, 7.5, 10, 15 and 20 mg, and statistical analysis of 7.5 mg and 10 mg was compared with placebo (unbalanced randomization). Compared with placebo, the 7.5 mg and 10 mg doses of zolpidem decreased sleep latency and increased sleep duration and maintenance (i.e. reduced number of awakenings). Zolpidem (7.5 mg or 10 mg) had no significant effect on next-day psychomotor performance. No statistically significant differences in the overall side-effect profiles were found between 7.5-mg and 10-mg zolpidem dose groups and placebo. This study demonstrates that zolpidem at 7.5 mg and 10 mg is effective in the treatment of transient insomnia.
短暂性失眠可能由压力、在不熟悉的环境中睡眠、时差反应及其他因素诱发。唑吡坦是一种新型咪唑吡啶类催眠药，已证实对大多数患者具有催眠作用，且对次日的表现无显著影响。本研究以睡眠实验室中的首夜效应作为短暂性失眠的模型，进行了一项安慰剂对照、双盲、平行组研究，评估了唑吡坦在462名正常志愿者中的疗效和安全性。对唑吡坦5、7.5、10、15和20毫克剂量进行了测试，并将7.5毫克和10毫克剂量与安慰剂进行统计学分析比较（非均衡随机分组）。与安慰剂相比，7.5毫克和10毫克剂量的唑吡坦可缩短入睡潜伏期，延长睡眠时间并改善睡眠维持情况（即减少觉醒次数）。唑吡坦（7.5毫克或10毫克）对次日的精神运动表现无显著影响。7.5毫克和10毫克唑吡坦剂量组与安慰剂组在总体副作用方面无统计学显著差异。本研究表明，7.5毫克和10毫克的唑吡坦对治疗短暂性失眠有效。
