Glass Jennifer R, Sproule Beth A, Herrmann Nathan, Busto Usoa E
Faculty of Pharmaceutical Sciences, University of Toronto, Toronto, Ontario, Canada.
J Clin Psychopharmacol. 2008 Apr;28(2):182-8. doi: 10.1097/JCP.0b013e31816a9e4f.
A randomized, controlled, crossover clinical study compared 14-night treatment with 15 mg temazepam, 50 mg diphenhydramine, and placebo in elderly individuals with insomnia (mean age, 73.9 years; range, 70-89 years). Primary outcome measures were subjective assessments of sleep recorded on sleep diaries. Secondary measures were the morning-after psychomotor impairment, using the digit symbol substitution task and the manual tracking task, and the morning-after memory impairment, using a free-recall procedure. Results showed sleep improvements with 15 mg temazepam compared with placebo-sleep quality (mean score, 3.3 +/- 0.9 vs 2.9 +/- 0.8; P = 0.03), total sleep time (6.9 +/- 1.0 hours vs 6.3 +/-1.3 hours; P = 0.02), number of awakenings (1.5 +/- 1.3 vs 2.0 +/- 1.2; P < 0.001), and sleep-onset latency (25 +/- 22 minutes vs 37 +/- 25 minutes; P = 0.03). Improvements were seen with diphenhydramine treatment compared with placebo on the number of awakenings only (mean, 1.7 +/- 1.1 vs 2.0 +/- 1.2; P < 0.05). Numbers of adverse events reported were similar after all treatments, although there was 1 fall during temazepam treatment. Findings indicate that temazepam is more effective than diphenhydramine when compared with placebo at the doses tested, although this advantage is mitigated by the risk of falls associated with temazepam use. The choice of agent to use in the elderly must consider these relative benefits and risks.
一项随机、对照、交叉临床研究比较了15毫克替马西泮、50毫克苯海拉明和安慰剂对老年失眠患者（平均年龄73.9岁；范围70 - 89岁）进行14晚治疗的效果。主要结局指标是睡眠日记中记录的睡眠主观评估。次要指标是使用数字符号替换任务和手动跟踪任务评估的次日早晨精神运动功能损害，以及使用自由回忆程序评估的次日早晨记忆损害。结果显示，与安慰剂相比，15毫克替马西泮可改善睡眠——睡眠质量（平均得分，3.3±0.9对2.9±0.8；P = 0.03）、总睡眠时间（6.9±1.0小时对6.3±1.3小时；P = 0.02）、觉醒次数（1.5±1.3对2.0±1.2；P < 0.001）和入睡潜伏期（25±22分钟对37±25分钟；P = 0.03）。与安慰剂相比，苯海拉明治疗仅在觉醒次数上有改善（平均，1.7±1.1对2.0±1.2；P < 0.05）。尽管替马西泮治疗期间有1例跌倒，但所有治疗后报告的不良事件数量相似。研究结果表明，在测试剂量下，与安慰剂相比，替马西泮比苯海拉明更有效，尽管这种优势因替马西泮使用相关的跌倒风险而有所减轻。在老年人中选择用药必须考虑这些相对的益处和风险。
