Abstract: Objective To analyze ADR induced by solriamfetol after listing via the FAERS (the US Food and Drug Administration Adverse Event Reporting System) so as to provide reference for clinical rational drug use. Methods The data on adverse reaction reports of solriamfetol submitted to the FAERS between January 1, 2019 and March 31, 2020 was retrieved and analyzed by MYSQL software. Results There were 122 ADR reports with solriamfetol as the primary suspected drug, 14 of which involved severe ADR. The main symptoms were psychiatric disorders, nervous system disorders, cardiac disorders, respiratory disorders, thoracic and mediastinal disorders. The top ten types of adverse reactions were anxiety, insomnia, paraesthesia, chest pain, sinus tachycardia, suicidal ideation, disturbance in attention, dizziness, headache and fatigue. Most of the people who reported discomfort were consumers, and the most of the patients with adverse reactions were female, with an average age of (31.95 ±15.26) years. Narcolepsy was the main manifestation, and the dose of 150 mg·d^-1 was the most common. 83.33% of the patients developed adverse reactions after less than one month of medication. Conclusion The analysis of the incidence of adverse reactions after the listing of solriamfetol by means suggests that we should pay more attention to this drug in the process of clinical application, keep in mind the indications of drug use and try every means available to ensure the safety of this drug.

Key words: solriamfetol, FAERS, adverse drug reaction