Feldmeier C, Kapp W
Br J Clin Pharmacol. 1983;16 Suppl 1(Suppl 1):151S-155S. doi: 10.1111/j.1365-2125.1983.tb02287.x.
The efficacy and safety of midazolam compared with oxazepam and placebo were investigated in 50 hospital patients (19 males, 31 females; age range 21 to 74 years) in a double-blind parallel group study. On the first 2 nights (selection phase), patients received only placebo. On the next 5 nights, they received either 15 mg midazolam, 15 mg oxazepam or placebo. They received no medication on the last 2 nights and were kept under observation (withdrawal phase). Compared with placebo, both benzodiazepines shortened sleep onset latency, reduced the number of awakenings and improved sleep quality. All 3 compounds were well tolerated with only few, mild side-effects (headache, nausea) in the 2 verum groups. Psychometric performance was not impaired on the morning following drug administration. The overall patients' assessments showed 80% satisfaction with midazolam, 66% with oxazepam and 10% with placebo. Midazolam and oxazepam yielded similar results, although midazolam induced sleep more rapidly and was rated more favourably by the patients. Midazolam, in a dose of 15 mg, is thus an effective, fast-acting, well-tolerated hypnotic without residual effects and is suitable for the treatment of insomnia of mild to moderate degree. Oxazepam in a dose of 15 mg is also well suited for the treatment of sleep disorders, particularly if a rapid onset of action is not required.
在一项双盲平行组研究中，对50名住院患者（19名男性，31名女性；年龄范围21至74岁）调查了咪达唑仑与奥沙西泮及安慰剂相比的疗效和安全性。在前两个晚上（筛选阶段），患者仅接受安慰剂。在接下来的五个晚上，他们接受15毫克咪达唑仑、15毫克奥沙西泮或安慰剂。在最后两个晚上他们不接受任何药物治疗，并接受观察（撤药阶段）。与安慰剂相比，两种苯二氮䓬类药物均缩短了入睡潜伏期，减少了觉醒次数并改善了睡眠质量。所有三种化合物耐受性良好，两个试验组中只有少数轻微副作用（头痛、恶心）。给药后次日早晨心理测量表现未受损害。患者的总体评估显示，对咪达唑仑的满意度为80%，对奥沙西泮的满意度为66%，对安慰剂的满意度为10%。咪达唑仑和奥沙西泮产生了相似的结果，尽管咪达唑仑诱导睡眠更快，且患者评价更高。因此，15毫克剂量的咪达唑仑是一种有效、起效快、耐受性良好且无残留效应的催眠药，适用于治疗轻度至中度失眠。15毫克剂量的奥沙西泮也非常适合治疗睡眠障碍，特别是如果不需要快速起效的话。
