Drug-associated insomnia: A pharmacovigilance study based on FDA adverse event reporting system

This pharmacovigilance study analyzed data from the FDA Adverse Event Reporting System from 2004 to 2024 to identify drug-related insomnia risks. It found 179,697 reports of insomnia linked to medications, with nervous system drugs being the most common culprits. The top medications associated with insomnia were mefloquine, viloxazine, and flibanserin. Subgroup analyses showed varying drug signal profiles by age and gender, highlighting specific risks such as finasteride in males and flibanserin in females. The study emphasizes the importance of clinical awareness of drug-induced sleep disturbances and calls for further research to validate these findings.