Sleep Disorders and Research Center, Henry Ford Hospital, Detroit, MI 48202, USA.
Sleep. 2012 Nov 1;35(11):1551-7. doi: 10.5665/sleep.2208.
To evaluate the long-term (8 months) efficacy of zolpidem in adults with chronic primary insomnia using polysomnography.
Randomized, double-blind, placebo-controlled clinical trial.
Sleep disorders and research center.
Healthy participants (n = 91), ages 23-70, meeting DSM-IV-TR criteria for primary insomnia.
Nightly zolpidem, 10 mg (5 mg for patients > 60 yrs) or placebo 30 minutes before bedtime for 8 months.
Polysomnographic sleep parameters and morning subject assessments of sleep on 2 nights in months 1 and 8. Relative to placebo, zolpidem significantly increased overall total sleep time and sleep efficiency, reduced sleep latency and wake after sleep onset when assessed at months 1 and 8. Overall, subjective evaluations of efficacy were not shown among treatment groups.
In adults with primary insomnia, nightly zolpidem administration remained efficacious across 8 months of nightly use.
ClinicalTrials.gov Identifier: NCT01006525; Trial Name: Safety and Efficacy of Chronic Hypnotic Use; http://clinicaltrials.gov/ct2/show/NCT01006525.
使用多导睡眠图评估佐匹克隆在慢性原发性失眠成人患者中的长期（8 个月）疗效。
随机、双盲、安慰剂对照临床试验。
睡眠障碍和研究中心。
健康参与者（n=91），年龄 23-70 岁，符合 DSM-IV-TR 原发性失眠标准。
每晚睡前 30 分钟服用佐匹克隆 10mg（60 岁以上患者 5mg）或安慰剂，持续 8 个月。
多导睡眠图睡眠参数和第 1 个月和第 8 个月 2 晚早晨的主观睡眠评估。与安慰剂相比，佐匹克隆在第 1 个月和第 8 个月时显著增加了总睡眠时间和睡眠效率，减少了睡眠潜伏期和睡眠起始后的醒来次数。总体而言，治疗组之间并未显示出主观疗效评估。
在原发性失眠的成人中，每晚使用佐匹克隆治疗 8 个月仍然有效。
ClinicalTrials.gov 标识符：NCT01006525；试验名称：慢性催眠药物使用的安全性和疗效；http://clinicaltrials.gov/ct2/show/NCT01006525。
