Trend changes of national zolpidem users and exposure cases after FDA drug safety communications
| Autor: | Joann Lee, Gerald J. Dal Pan, Esther H. Zhou, Travis Ready, Ellen Pinnow, Daniel Bak, Zhou Feng |
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| Rok vydání: | 2021 |
| Předmět: |
Male
Drug Zolpidem Epidemiology Initial dose media_common.quotation_subject Population Humans Hypnotics and Sedatives Medicine Pharmacology (medical) education media_common Time varying confounding education.field_of_study United States Food and Drug Administration business.industry Communication musculoskeletal neural and ocular physiology Interrupted time series Interrupted Time Series Analysis Absolute level United States Pharmaceutical Preparations Anesthesia Safety Communications Female business psychological phenomena and processes medicine.drug |
| Zdroj: | Pharmacoepidemiology and Drug Safety. 30:1551-1559 |
| ISSN: | 1099-1557 1053-8569 |
| DOI: | 10.1002/pds.5344 |
| Popis: | Purpose To evaluate the impact of FDA's 2013 zolpidem Drug Safety Communications (DSCs), which recommended lowering the initial dose to mitigate drowsiness, on national estimates of zolpidem users and zolpidem exposure cases. Methods We analyzed trend changes of national zolpidem users from the IQVIA Total Patient Tracker (TPT) and zolpidem exposure cases reported to the National Poison Data System (NPDS), 2009-2018. To control for time varying confounding, the adjusted trends were analyzed using simple and controlled interrupted time series (ITS). We also adjusted for seasonal changes. Three sedating antidepressants were used together as a control. Results The national estimates of high-dose zolpidem users in TPT decreased significantly in the month immediately post-DSC; the absolute level decrease was -12.51 (95% CI: -14.12, -10.89) per 10 000 U.S. population relative to sedating antidepressants. The trend continuously decreased post-DSC, resulting in a 59% overall decrease by the end of the study period. There was a larger decrease in high-dose zolpidem use in females than in males. There was a level decrease of zolpidem exposure cases in the NPDS immediately post-DSC, -0.37 absolute decline (95% CI, -0.53, -0.20) per 10 000 national zolpidem users; or - 1.33 absolute decline (95% CI, -1.54, -1.13) per 1000 total NPDS exposure cases relative to sedating antidepressants. Similar patterns were observed for cases reporting drowsiness. The results from the single ITS and controlled ITS were similar. Conclusions Zolpidem users and exposure cases decreased significantly post-DSC, suggesting practitioners and patients became aware of and responded to the zolpidem DSCs. This article is protected by copyright. All rights reserved. |
| Databáze: | OpenAIRE |
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