Schedules of Controlled Substances: Placement of Solriamfetol in Schedule IV

On March 20, 2019, the U.S. Food and Drug Administration approved a new drug application for SUNOSI, a drug product consisting of solriamfetol ((R)-2-amino-3-phenylpropyl carbamate hydrochloride) tablets for oral use. Thereafter, the Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place solriamfetol in schedule IV of the Controlled Substances Act (CSA). In accordance with the CSA, as revised by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing solriamfetol, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule IV of the CSA.