2026 CONVENTION
Comparative profiles of sleep-related adverse events across SSRIs, SNRIs, and SARIs: an international pharmacovigilance database
Background: Antidepressants are associated with sleep-related adverse events, but reporting patterns across phenotypes and classes remain incompletely characterized. Methods: We analyzed FAERS data from 2005 to 2024 for 17 antidepressants classified as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or serotonin antagonist and reuptake inhibitors (SARIs). Only primary suspect drugs were included. Sleep-related adverse events were identified using MedDRA Preferred Terms. After deduplication, reporting frequency and disproportionality were assessed using reporting odds ratios (RORs) and information components (ICs). Results: Among 2,443 reports, 40.89% involved males. SSRIs showed the highest overall disproportionality (ROR, 4.44 [95% CI, 4.21–4.68]). Escitalopram showed the highest disproportionality among individual antidepressants. Somnolence was most frequently reported, whereas stronger signals were observed for sleep terror, sleep talking, and abnormal dreams. SSRIs showed prominent signals for these phenotypes, whereas SNRIs and SARIs showed somnolence-dominant profiles. Disproportionality was higher among males for antidepressants overall and SSRIs, but among females for SNRIs. Conclusions: Antidepressant-associated sleep-related adverse events showed heterogeneous disproportionality across classes, phenotypes, and sex. Phenotype-specific signals warrant further evaluation in longitudinal and real-world data.