唑吡坦治疗老年原发性失眠的开放性前瞻性多中心自身对照研究

目的 评价唑吡坦5 mg每日1次治疗老年原发性失眠的疗效和安全性.方法 采用开放性、前瞻性、固定剂量、多中心、自身对照的研究方法.115例符合美国精神障碍诊断和统计手册第4版原发性失眠诊断标准的老年门诊患者每日1次服用固定剂量唑吡坦5 mg,疗程3周.以治疗第1周末匹兹堡睡眠质量指数评分(PSQI)相对于基线的差值作为研究的主要疗效评价指标,次要疗效指标包括:治疗第3周末PSQI评分相对于基线的差值,治疗第1周末和第3周末主观睡眠有效参数评分(睡眠潜伏期、总的睡眠时间、睡眠质量)相对于基线的差值,治疗第3周末17项汉密尔顿抑郁量表(HAMD-17)评分和汉密尔顿焦虑量表(HAMA)评分相对于基线的差值.结果 治疗第1周末,PSQI量表总分较基线下降2.8分,差异有统计学意义(P＜0.01);治疗第3周末,PSQI评分较基线下降3.2分,差异有统计学意义(P＜0.01);治疗第1周末和第3周末主观睡眠有效参数均有明显改善:睡眠潜伏期缩短(P＜0.01),睡眠时间延长(P＜0.01),日间功能提高(P＜0.01);治疗第3周末,患者的HAMD-17和HAMA评分较基线均有降低(P＜0.01);不良事件的发生率为19.1%,主要为头晕、头痛、困倦、恶心、乏力等,程度为轻、中度.结论 每日1次服用固定剂量唑吡坦5 mg治疗老年原发性失眠安全有效.

Efficacy and safety of zolpidem in treatment of primary insomnia in Chinese elderly: an open, selfcontrolled, multicenter study

Objective To evaluate the clinical efficacy and safety of zolpidem in treatment of primary insomnia in elderly patients.Methods An open, perspective, fixed-dose, multicentre and selfcontrolled clinical trial was conducted.Total of 115 elderly patients who met with the Diagnostic and Statistical Manual of Mental Disorders, 4th edition criteria for primary insomnia were administered 3 week nightly treatment with zolpidem 5 mg.The primary efficacy measurement was the change of Pittsburg Sleep Quality Index(PSQI) score after 1 week treatment in comparison with the baseline.The secondary efficacy measurement included the changes from baseline in total score of the PSQI, Hamilton Depression Scale (HAMD-17) and Hamilton Anxiety Scale (HAMA) and self-reported sleeping parameters ( latency of falling asleep, total sleeping time and sleeping quality) after 3 week treatment.Results The mean reduction score 17 items of PSQI were 2.8 after 1 week treatment and 3.2 at the end of 3 week ( P ＜ 0.01 ).The selfreported sleeping parameters were much improved from the baseline (P ＜0.01 ).The total scores of HAMD and HAMA were reduced significantly ( P ＜ 0.01 ) after 3 week treatment.The overall incidence of adverse events was 19.1%, with the frequent adverse events of dizziness, headache, sleepiness, nausea and fatigue, and the severity was mild or moderate.Conclusion It is effective and safe of zolpidem 5 mg nightly in treatment of elderly insomnia patients.