Sogawa Rintaro, Hatano Masakazu, Nishimura Fumi, Nishi Junya, Matsuoka Ayaka, Shinada Kota, Yamada Haruna, Tateishi Hiroshi, Mizoguchi Yoshito, Monji Akira, Shimanoe Chisato
Department of Pharmacy, Saga University Hospital, Nabeshima, Japan;
Department of Pharmacotherapeutics and Informatics, Fujita Health University School of Medicine, Toyoake, Japan.
In Vivo. 2025 Jan-Feb;39(1):433-439. doi: 10.21873/invivo.13846.
BACKGROUND/AIM: The use of hypnotic drugs can lead to accidents and injuries. However, few reports have shown their association with these events after adjusting for many concomitant medications. This study aimed to determine whether the use of hypnotic drugs was associated with accidents and injuries.
Using the Japanese Adverse Event Reporting Database, 772,387 reports published between September 2023 and April 2004 were analyzed. Reporting odds ratios (RORs) and 95% confidence intervals (CIs) for accidents and injuries associated with each hypnotic drug were calculated after adjusting for potential confounders.
Of the total, 12,484 reports indicated association of hypnotic drugs with accidents and injuries. The use of each hypnotic drug was associated with accidents, injuries, and other adverse events. However, a multivariate analysis adjusted for age, sex, reporting year, and concomitant medications showed a considerable decrease in ROR for melatonin receptor agonists (adjusted ROR=1.26; 95%CI=1.03-1.55) and dual orexin receptor antagonists (DORAs) (adjusted ROR=1.04; 95%CI=0.86-1.25). Particularly in DORAs, a loss of signal for accidents and injuries was observed.
The risk of accidents and injuries may vary with hypnotic drug use; however, DORAs may be less frequently associated with these events. The results of this study provide useful information for the selection of hypnotic drugs.
背景/目的：使用催眠药物可能导致事故和伤害。然而，在对多种合并用药进行调整后，很少有报告显示它们与这些事件之间的关联。本研究旨在确定使用催眠药物是否与事故和伤害有关。
使用日本不良事件报告数据库，分析了2003年9月至2004年4月期间发表的772387份报告。在对潜在混杂因素进行调整后，计算了每种催眠药物相关的事故和伤害的报告比值比（ROR）和95%置信区间（CI）。
总共12484份报告表明催眠药物与事故和伤害有关。每种催眠药物的使用都与事故、伤害和其他不良事件有关。然而，在对年龄、性别、报告年份和合并用药进行多变量分析后，褪黑素受体激动剂（调整后的ROR = 1.26；95%CI = 1.03 - 1.55）和双食欲素受体拮抗剂（DORAs）（调整后的ROR = 1.04；95%CI = 0.86 - 1.25）的ROR显著降低。特别是在DORAs中，观察到事故和伤害的信号消失。
事故和伤害的风险可能因催眠药物的使用而异；然而，DORAs与这些事件的关联可能较少。本研究结果为催眠药物的选择提供了有用信息。
