Trend changes of national zolpidem users and exposure cases after FDA drug safety communications

摘要

Purpose: To evaluate the impact of FDA's 2013 zorpidem Drug Safety Communications (DSCs), whicft 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 fortime varying confounding, the adjusted trehds'were analyzed 'using simple atid controlled interrupted time series '(ITS). We also adjusted for "seasonal changes. Three sedating antidepressants were used together as a control.