Gallais H, Casanova P, Fabregat H
Br J Clin Pharmacol. 1983;16 Suppl 1(Suppl 1):145S-149S. doi: 10.1111/j.1365-2125.1983.tb02286.x.
Fifty-nine hospitalized patients participated in a double-blind study: 19 received 15 mg midazolam, 20 received 50 mg oxazepam, and 20 placebo. The three groups were comparable with regard to age, sex, height, weight, and degree and type of insomnia. The sleep-onset latency was shorter with midazolam than with placebo or oxazepam (Mann-Whitney test, alpha less than 0.05). With regard to total sleep duration and the number of nocturnal awakenings, there was no difference between the midazolam and oxazepam groups, whereas there was a difference between these two groups and placebo. More subjects of the midazolam group felt calm and refreshed on awakening. Safety, assessed by clinical examination and laboratory tests, was excellent. This study confirms the usefulness of midazolam in treating 'early' insomnia, i.e. difficulty in falling asleep.
59名住院患者参与了一项双盲研究：19人接受15毫克咪达唑仑，20人接受50毫克奥沙西泮，20人接受安慰剂。三组在年龄、性别、身高、体重以及失眠的程度和类型方面具有可比性。咪达唑仑组的入睡潜伏期比安慰剂组或奥沙西泮组短（曼-惠特尼检验，α<0.05）。在总睡眠时间和夜间觉醒次数方面，咪达唑仑组和奥沙西泮组之间没有差异，而这两组与安慰剂组之间存在差异。咪达唑仑组更多的受试者醒来时感觉平静且精神焕发。通过临床检查和实验室测试评估的安全性极佳。这项研究证实了咪达唑仑在治疗“早期”失眠即入睡困难方面的有效性。
