Frattola L, Maggioni M, Cesana B, Priore P
V Neurological Department, University of Milan, Italy.
Drugs Exp Clin Res. 1990;16(7):371-6.
The efficacy of zolpidem 20 mg was compared to that of flunitrazepam 2 mg. Forty-two insomniac female in-patients between 30 and 65 years of age were included in a double blind, parallel group trial and were randomly allocated to the two treatments. Study duration was 9 days with 2 days of placebo run-in, 5 days of active medication and 2 days of placebo withdrawal. Sleep latency, sleep duration, number of awakenings and time spent asleep during the night were given an ordinal score; condition in the morning was evaluated by Visual Analogue Scales and the psychomotor performance was evaluated by the tests: night-day for anterograde amnesia, digit span for verbal recall and Grünberger's fine motor function test. There was no significant difference between zolpidem and flunitrazepam for any of the variables; the drugs were significantly better than placebo baseline for all the sleep efficacy variables. The results of this study indicate that zolpidem is as effective as flunitrazepam in inducing and maintaining sleep but it does not induce a sense of weakness in the morning and does not impair memory.
将唑吡坦20毫克的疗效与氟硝西泮2毫克的疗效进行了比较。42名年龄在30至65岁之间的失眠女性住院患者被纳入一项双盲平行组试验，并被随机分配到两种治疗组。研究持续时间为9天，包括2天的安慰剂导入期、5天的活性药物治疗期和2天的安慰剂撤药期。睡眠潜伏期、睡眠时间、夜间觉醒次数和夜间睡眠时间被给予一个序贯评分；早晨的状况通过视觉模拟量表进行评估，精神运动表现通过以下测试进行评估：用于顺行性遗忘的昼夜测试、用于言语回忆的数字广度测试和格伦伯格精细运动功能测试。对于任何变量，唑吡坦和氟硝西泮之间均无显著差异；对于所有睡眠疗效变量，这两种药物均显著优于安慰剂基线。这项研究的结果表明，唑吡坦在诱导和维持睡眠方面与氟硝硝西坦同样有效，但它不会在早晨引起虚弱感，也不会损害记忆力。
