March 3, 2026Frontiers in Pharmacology0 citationsOpen Access

Real-world data on the abuse potential of medications for the treatment of insomnia: a disproportionality analysis of the FAERS database

PSPaul SaskinIdera Pharmaceuticals (United States)WMW. Vaughn McCallAugusta University DNDavid N. NeubauerJohns Hopkins University

Key Points

Reported cases of abuse were significantly fewer for DORAs than for trazodone or Z-drugs, indicating a lower inherent risk.
Among the medications studied, DORAs demonstrated fewer incidents of misuse and overdose than unscheduled trazodone.
Disproportionality analysis using the FAERS database examined safety risks across multiple medications for insomnia.
Findings suggest that the Schedule IV classification of DORAs may be unnecessarily strict regarding abuse potential.

Abstract

This study identified significantly fewer reported cases of real-world abuse, misuse, overdose, and other safety risks for DORAs compared with the unscheduled drug trazodone and scheduled Z-drugs. This suggests that categorization of DORAs as Schedule IV drugs may overstate their abuse potential.

问 AI

Bookmark

View Full Paper