Roth Thomas, Soubrane Christina, Titeux Laurence, Walsh James K
Henri Ford Hospital, Detroit, MI 48202, USA.
Sleep Med. 2006 Aug;7(5):397-406. doi: 10.1016/j.sleep.2006.04.008. Epub 2006 Jul 3.
To evaluate the clinical efficacy and safety of modified-release zolpidem (zolpidem-MR 12.5mg) for the treatment of primary insomnia in adults.
Two hundred and twelve (123 women, 89 men; mean age 44.3+/-SD 3.0 years), Diagnostic and Statistical Manual of Mental Disorders--4th Edition (DSM-IV)-defined primary insomnia patients were randomized in a double-blind, placebo-controlled, parallel-group study. The study was completed by 192 patients. Patients received 3 weeks of nightly treatment with either zolpidem-MR 12.5mg or placebo, preceded and followed by two nights of single-blind placebo. The main outcome measures were mean polysomnographic (PSG) sleep parameters of nights 1/2 and nights 15/16 of double-blind treatment and daily subjective sleep estimates from sleep questionnaires to assess efficacy, and PSG parameters of nights 22 and 23 of single-blind placebo substitution to assess the effect of drug discontinuation.
Relative to placebo, zolpidem-MR 12.5mg improved sleep maintenance by significantly reducing PSG wake time after sleep onset (WASO) during the first 6h of sleep as well as the number of awakenings. Consistent with the effects of standard zolpidem, zolpidem-MR also significantly reduced latency to persistent sleep, and significantly increased sleep efficiency, both at the beginning and after 2 weeks of double-blind treatment. There was no evidence of next-day residual effects as measured objectively by psychometric tests. Rebound insomnia on the first night after abrupt discontinuation resolved the following night. Overall, zolpidem-MR was well tolerated.
Zolpidem-MR 12.5mg is effective and safe in treating primary insomnia in adults and improves sleep maintenance, induction and duration of sleep.
评估缓释唑吡坦（唑吡坦 - MR 12.5mg）治疗成人原发性失眠的临床疗效和安全性。
212名（123名女性，89名男性；平均年龄44.3±标准差3.0岁）符合《精神疾病诊断与统计手册》第4版（DSM - IV）定义的原发性失眠患者，被随机分配至一项双盲、安慰剂对照、平行组研究。该研究由192名患者完成。患者接受为期3周的每晚治疗，治疗药物为唑吡坦 - MR 12.5mg或安慰剂，治疗前后各有两晚单盲安慰剂治疗。主要疗效指标为双盲治疗第1/2晚和第15/16晚的平均多导睡眠图（PSG）睡眠参数，以及来自睡眠问卷的每日主观睡眠评估以评估疗效，单盲安慰剂替代治疗第22晚和第23晚的PSG参数以评估停药效果。
相对于安慰剂，唑吡坦 - MR 12.5mg通过显著减少睡眠开始后最初6小时的PSG觉醒时间（WASO）以及觉醒次数，改善了睡眠维持情况。与标准唑吡坦的效果一致，唑吡坦 - MR在双盲治疗开始时和2周后也显著缩短了持续睡眠潜伏期，并显著提高了睡眠效率。心理测量测试客观测量结果显示，没有次日残留效应的证据。突然停药后第一晚出现的反跳性失眠在第二晚得到缓解。总体而言，唑吡坦 - MR耐受性良好。
唑吡坦 - MR 12.5mg治疗成人原发性失眠有效且安全，可改善睡眠维持、诱导和睡眠时间。
