CLINICAL SAFETY OF SOLRIAMFETOL: A PHARMACOVIGILANCE INVESTIGATION OF THE SPONTANEOUS REPORTS IN THE FDA ADVERSE EVENT REPORTING SYSTEM

Abstract

Background: Solriamfetol has been sanctioned to alleviate daytime drowsiness linked to obstructive sleep apnea and narcolepsy. Nonetheless, there are no reports on the prolonged safety of solriamfetol in a broad patient demographic. In this report, we scrutinized adverse events (AEs) related to Solriamfetol by analyzing information from the US Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: Data extracted from FAERS spanning between March 2019 and December 2022 were reviewed and scrutinized. Methodologies such as reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker algorithms were harnessed to measure risk factors that indicate solriamfetol-linked AEs. Results: In all, 1,298 cases where solriamfetol was the “primary suspected” (PS) drug and 526 AEs attributed to solriamfetol were identified. These AEs affected 27 system organ classes.  Common significant signals of anxiety, irritability, headache, blood pressure increased, heart rate increased, palpitations, tachycardia, dry mouth have emerged. Unexpected significant AEs such as depression, suicidal ideation, tremor, hyperhidrosis, and drug ineffective occurred. Conclusion: Our research has identified novel AEs for solriamfetol, providing information on solriamfetol safety profiles, and supporting its judicious application in Sleep-related disorders.