Greater incidence of depression with hypnotic use than with placebo.
Greater incidence of depression with hypnotic use than with placebo.
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与安慰剂相比，使用催眠的抑郁症发生率更大。
DOI：
10.1186/1471-244x-7-42
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发表时间：
2007-08-21
期刊：
影响因子：
4.4
通讯作者：
Kripke DF
中科院分区：
文献类型：
--
作者：
Kripke DF
尽管有人声称失眠会增加患抑郁症的风险，但尚未有足够的对照试验来检验这一假设。这项研究将随机对照试验中接受安眠药的受试者与接受安慰剂的受试者的抑郁症发生率进行了对比。随机接受催眠药物或安慰剂的患者抑郁症的发生率是根据美国食品和药物管理局 (FDA) 批准的处方信息以及 FDA 新药申请文件编制的。获取了唑吡坦、扎来普隆、艾司佐匹克隆和雷美替胺的可用数据。收集了 5535 名随机接受催眠药的患者和 2318 名随机接受安慰剂的患者的数据。随机接受催眠药的参与者抑郁症的发生率为 2.0%，而随机接受安慰剂的参与者的抑郁发生率为 0.9%（p < 0.002）。 FDA 发布的数据显示，现代安眠药与抑郁症发病率增加有关。这表明，当存在抑郁风险时，安眠药可能是禁忌的。抗抑郁药物、认知行为疗法或强光等预防性治疗可能是首选。 FDA 数据的局限性阻碍了正式的荟萃分析，并且缺乏有关辍学率和抑郁症定义的信息。专门设计用于检测用安眠药治疗失眠时发生的抑郁症的试验以及在提交给 FDA 的试验中更好地总结不良事件都是必要的。
Although it has been claimed that insomnia causes an increased risk for depression, adequate controlled trials testing this hypothesis have not been available. This study contrasted the incidence of depression among subjects receiving hypnotics in randomized controlled trials versus those receiving placebo. The incidence of depression among patients randomized to hypnotic drugs or placebo was compiled from prescribing information approved by the United States Food and Drug Administration (FDA) and from FDA New Drug Application documents. Available data for zolpidem, zaleplon, eszopiclone, and ramelteon were accessed. Data for 5535 patients randomized to a hypnotic and for 2318 randomized to placebo were compiled. The incidence of depression was 2.0% among participants randomized to hypnotics as compared to 0.9% among those randomized in parallel to placebo (p < 0.002). Modern hypnotics were associated with an increased incidence of depression in data released by the FDA. This suggests that when there is a risk of depression, hypnotics may be contra-indicated. Preventive treatments such as antidepressant drugs, cognitive-behavioral therapy, or bright light might be preferred. Limitations in the FDA data prevented a formal meta-analysis, and there was a lack of information about drop-out rates and definitions of depression. Trials specifically designed to detect incident depression when treating insomnia with hypnotic drugs and better summarization of adverse events in trials submitted to the FDA are both necessary.