国产扎来普隆治疗失眠症的多中心随机双盲对照研究

目的：评价国产扎来普隆胶囊治疗失眠症的有效性和安全性。方法：多中心、随机、双盲、双模拟、阳性药平行对照研究，209例失眠症患者随机分为扎来普隆组（105例）与唑吡坦组（104例）,分别口服扎来普隆胶囊10mg&#8226;d-1或唑吡坦片10mg&#8226;d-1，疗程14天。结果：睡眠障碍量表总评分在治疗结束时两组较基线均显著减少(p<0.01)；有效率扎来普隆组为62.7%与唑吡坦组为61.0%，差异无显著性 (p>0.05)。扎来普隆较常见的不良反应为：头晕、头昏、口苦，未出现严重的不良反应。结论：国产扎来普隆胶囊治疗失眠症安全、有效。

A Multicenter, Randomized and Double-blind Controlled Clinical Trial of Zaleplon and zolpidem for Treatment of Insomnia

Objective To evaluate the efficacy and safety of domestic zaleplon in the treatment of insomnia.Methods We conducted a multicenter,randomized,double-blind,controlled clinical trial.A total of 209 patients with insomnia were randomly assigned to receive a single 10 mg oral dose of either zaleplon(n = 105),or zolpidem(n = 104) daily for 14 days.Results The scores on rating scale for sleep dysfunction in both groups were significantly reduced at the end of treatment as compared with the baseline(P < 0.01=.There was no significant difference in the efficacy rate between the zaleplon therapy and the zolpidem therapy(62.7% vs 61.0%,P > 0.05).The common adverse effects with zaleplon were lightheadedness,dizziness,and a bitter taste in mouth.No severe adverse events occurred.Conclusion Domestic zaleplon is effective and safe for insomnia.