Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.
Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
Pharmacoepidemiol Drug Saf. 2020 Mar;29(3):352-356. doi: 10.1002/pds.4952. Epub 2020 Jan 9.
To identify possible changes in U.S. emergency department (ED) visits from zolpidem-attributed adverse drug reactions (ADRs) after 2013 Food and Drug Administration (FDA) Drug Safety Communications (DSCs), which notified the public about FDA's new dosing recommendations for zolpidem.
We estimated the occurrence of ED visits from zolpidem-attributed ADRs using nationally representative, public health surveillance of medication harms (National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project, 2010-2017). We estimated the number of zolpidem prescriptions using IQVIA National Prescription Audit, 2010-2017. We calculated rates of ED visits for zolpidem-attributed ADRs per 10 000 dispensed zolpidem prescriptions and identified time trends and potential inflection points using joinpoint regression. For comparison, we repeated these analyses for sedating antidepressants commonly used to treat disordered sleep (trazodone, doxepin, and mirtazapine).
The best-fit regression model for rates of ED visits for zolpidem-attributed ADRs by 6-month intervals identified a single inflection point in the second half of 2014 ( = .024) with a 6.7% biannual decrease from 2010 to 2014 ([-13.1%, 0.3%], = .059) and a 13.9% biannual increase from the second half of 2014 through 2017 ([-1.1%, 31.3%], = .068). No change or inflection points were identified for rates of ED visits for sedating antidepressant-attributed ADRs.
While there was a nominal decline in the rate of ED visits for ADRs in the time period before and for 18 months after FDA's 2013 zolpidem DSCs, the decrease was not sustained, and thus questions remain concerning the long-term impact of the zolpidem DSCs on ADRs.
确定美国 2013 年食品和药物管理局（FDA）药物安全通讯（DSC）通知公众 FDA 对唑吡坦新剂量建议后，因唑吡坦不良药物反应（ADR）而导致的急诊科就诊情况是否发生变化。
我们使用全国范围内具有代表性的药物伤害公共卫生监测（国家电子伤害监测系统-合作不良药物事件监测项目，2010-2017 年），估计因唑吡坦 ADR 而导致的急诊科就诊人数。我们使用 IQVIA 国家处方审计（2010-2017 年）估计唑吡坦处方数量。我们计算了每 10000 张开出的唑吡坦处方因唑吡坦 ADR 而导致的急诊科就诊率，并使用 Joinpoint 回归确定时间趋势和潜在拐点。为了比较，我们对常用于治疗睡眠障碍的镇静性抗抑郁药（曲唑酮、多塞平和米氮平）进行了重复分析。
通过 6 个月间隔的 ED 就诊率最佳拟合回归模型确定了 2014 年下半年的一个单一拐点（=0.024），与 2010 年至 2014 年期间每年下降 6.7%（[-13.1%，0.3%]，=0.059）相比，2014 年下半年至 2017 年期间每年增加 13.9%（[-1.1%，31.3%]，=0.068）。镇静性抗抑郁药相关 ADR 的 ED 就诊率未发生变化或未出现拐点。
虽然在 FDA 2013 年唑吡坦 DSC 之前和之后的 18 个月期间，因 ADR 而导致的急诊科就诊率有名义上的下降，但这种下降并未持续，因此关于唑吡坦 DSC 对 ADR 的长期影响仍存在疑问。
