Post-marketing safety of solriamfetol: A retrospective pharmacovigilance study based on the us food and drug administration adverse event reporting system.

ABSTRACT:

Purpose

Excessive daytime sleepiness (EDS) seriously affects quality of life and may increase the risk of life-threatening situations, such as motor vehicle accidents. Solriamfetol is a novel medication approved for the treatment of EDS and serves as an alternative to traditional stimulants. This retrospective pharmacovigilance study aimed to analyze adverse events (AEs) related to solriamfetol based on real-world data.

Methods

Data regarding solriamfetol-related adverse events were retrieved from the FDA Adverse Event Reporting System (FAERS) from Q3 of 2019 to Q1 of 2024. A total of 1550 reports on solriamfetol-related AEs were analyzed using disproportionality analysis to identify AE signals across various organ systems.

Results

A large proportion of AEs were repor

SUBMITTER: Wu L 

PROVIDER: S-EPMC12453233 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature