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

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.