Real-world disproportionality analysis of sleep disturbances associated with antiseizure medications in epilepsy: a pharmacovigilance study.

ABSTRACT:

Objective

Real-world evidence characterizing the safety profiles of antiseizure medications (ASMs) concerning sleep disturbances remains limited. This study aimed to systematically evaluate the reporting patterns and safety signals of ASMs-related sleep disturbances using data from the FDA Adverse Event Reporting System (FAERS).

Methods

We conducted a retrospective pharmacovigilance study using FAERS data from Q1 2004 to Q2 2025. Disproportionality analyses were performed to identify potential safety signals for sleep-related adverse events (sAEs) associated with ASMs. We further analyzed demographic characteristics, clinical manifestations, and time-to-onset profiles.

Results

Analysis of 3,118 reports identified significant associations between multiple ASMs and slee

SUBMITTER: Gou C 

PROVIDER: S-EPMC12741064 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature