Medical Research Collaborating Center, Seoul National University Hospital, Seoul, Republic of Korea.
Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, Seoul, Republic of Korea.
CNS Drugs. 2018 Jun;32(6):593-600. doi: 10.1007/s40263-018-0520-x.
Zolpidem is one of the most frequently used hypnotics worldwide, but associations with serious adverse effects such as motor vehicle collisions have been reported.
The objective of this study was to evaluate the association of fatal motor vehicle collisions with a prescription for zolpidem, considering the context of the motor vehicle collisions.
We conducted a case-crossover study, where each case served as its own control, by linking data about fatal motor vehicle collisions from the Korean Road Traffic Authority between 2010 and 2014 with national health insurance data. The case period was defined as 1 day before the fatal motor vehicle collisions, and was matched to four control periods at 90-day intervals. Conditional logistic regression was performed to calculate the odds ratio for fatal motor vehicle collisions associated with zolpidem exposure, and odds ratios were adjusted for time-varying exposure to confounding medications. A stratified analysis was performed by age group (younger than 65 years or not), the Charlson Comorbidity Index, and whether patients were new zolpidem users.
Among the 714 subjects, the adjusted odds ratio for a fatal motor vehicle collision associated with a prescription for zolpidem the previous day was 1.48 (95% confidence interval 1.06-2.07). After stratification, a significantly increased risk was observed in subjects with a high Charlson Comorbidity Index (odds ratio 1.81; 95% confidence interval 1.16-2.84), the younger age group (odds ratio: 1.62; 95% confidence interval 1.03-2.56), and new zolpidem users (odds ratio 2.37; 95% confidence interval 1.40-4.00).
A prescription for zolpidem on the previous day was significantly related to an increased risk of fatal motor vehicle collisions in this population-based case-crossover study.
唑吡坦是全球使用最广泛的催眠药之一，但已有报道称其与严重不良反应相关，如机动车事故。
本研究旨在评估在考虑机动车事故背景的情况下，开处方使用唑吡坦与致命性机动车事故之间的关联。
我们开展了一项病例交叉研究，通过将 2010 年至 2014 年期间韩国道路交通管理局的致命性机动车事故数据与国家健康保险数据相链接，利用每个病例作为自身对照来进行研究。病例期定义为致命性机动车事故前一天，与以 90 天为间隔的 4 个对照期相匹配。采用条件逻辑回归计算与唑吡坦暴露相关的致命性机动车事故的比值比，并根据随时间变化的混杂药物暴露情况对比值比进行调整。按照年龄组（＜65 岁或≥65 岁）、Charlson 合并症指数和患者是否为新唑吡坦使用者进行分层分析。
在 714 名受试者中，前一天开处方使用唑吡坦与致命性机动车事故相关的调整比值比为 1.48（95%置信区间 1.06-2.07）。分层后，Charlson 合并症指数较高（比值比 1.81；95%置信区间 1.16-2.84）、年龄较小的受试者（比值比 1.62；95%置信区间 1.03-2.56）和新唑吡坦使用者（比值比 2.37；95%置信区间 1.40-4.00）中观察到风险显著增加。
在这项基于人群的病例交叉研究中，前一天开处方使用唑吡坦与致命性机动车事故风险增加显著相关。
