Uchimura Naohisa, Nakajima Toru, Hayash Kunihiko, Nose Iwao, Hashizume Yuji, Ohyama Tetsu, Habukawa Mitsunari, Kotorii Nozomu, Kuwahara Hiroo, Maeda Hisao
Department of Neuropsychiatry, Kurume University School of Medicine, 67 Asahi-cho, Kurume, Japan.
Prog Neuropsychopharmacol Biol Psychiatry. 2006 Jan;30(1):22-9. doi: 10.1016/j.pnpbp.2005.06.018. Epub 2005 Jul 25.
This study was conducted to determine the effect of zolpidem (ZOL) 10 mg orally on the sleep architecture and the next-morning residual effect in patients with non-organic insomnia (ICD-10) as compared to the effect of brotizolam (BTM) 0.25 mg orally, a widely used short-acting benzodiazepine (BZD) hypnotic in Japan, in a randomized, crossover comparative study. Fourteen patients with non-organic insomnia (3 males and 11 females; mean age of 54.9+/-S.D. 8.9 years). First three nights with placebo, middle three nights with either ZOL 10 mg or BTM 0.25 mg, and last three nights again with placebo in each session (a total of two sessions). Primary endpoints were polysomnography findings of sleep stages, sleep parameters, and sleep latency (SL) in the morning to examine calculable sleepiness as a residual effect. Secondary endpoint was sleep quality assessed by self-assessment questionnaire. At 150 min after Tmax, both ZOL and BTM significantly increased stage 2 (S2), and ZOL showed significantly longer slow wave sleep (SWS; stage 3+4) as compared to BTM. Stage wake was significantly increased by ZOL at the first withdrawal night and by BTM at the second withdrawal night. ZOL did not affect SL after rising, whereas BTM showed significantly shorter SL. Both drugs reduced the number of nocturnal awakenings and improved subjective sleep quality. The common adverse drug reaction (ADR) was sleepiness (3 patients) in each treatment. All events were mild. No serious adverse events occurred. ZOL is as effective as BTM in improving subjective sleep quality in patients with psychophysiological insomnia (PPI). ZOL has advantages over BTM in having a unique profile of increasing SWS with less next-morning residual effect.
本研究旨在通过一项随机交叉对比研究，确定口服10毫克唑吡坦（ZOL）对非器质性失眠（ICD - 10）患者睡眠结构及次晨残留效应的影响，并与口服0.25毫克溴替唑仑（BTM）（日本广泛使用的短效苯二氮䓬（BZD）催眠药）的效果进行比较。14例非器质性失眠患者（3例男性，11例女性；平均年龄54.9±标准差8.9岁）。每个疗程的前三个晚上服用安慰剂，中间三个晚上服用10毫克ZOL或0.25毫克BTM，最后三个晚上再次服用安慰剂（共两个疗程）。主要终点是睡眠阶段、睡眠参数的多导睡眠图结果以及早晨的睡眠潜伏期（SL），以检查作为残留效应的可计算的嗜睡情况。次要终点是通过自我评估问卷评估的睡眠质量。在达峰时间（Tmax）后150分钟，ZOL和BTM均显著增加了2期睡眠（S2），并且与BTM相比，ZOL的慢波睡眠（SWS；3 + 4期）显著更长。在第一次撤药夜，ZOL使觉醒期显著增加，在第二次撤药夜，BTM使觉醒期显著增加。ZOL对起床后的SL没有影响，而BTM的SL显著缩短。两种药物均减少了夜间觉醒次数并改善了主观睡眠质量。每种治疗中常见的药物不良反应（ADR）是嗜睡（3例患者）。所有事件均为轻度。未发生严重不良事件。在改善心理生理性失眠（PPI）患者的主观睡眠质量方面，ZOL与BTM一样有效。ZOL比BTM具有优势，其独特之处在于增加SWS且次晨残留效应较小。
