Schedules of Controlled Substances: Placement of Daridorexant in Schedule IV

On January 7, 2022, the United States Food and Drug Administration approved a new drug application for QUIVIVIQ (daridorexant) tablets for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. The Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place daridorexant and its salts in schedule IV of the Controlled Substances Act (CSA). In accordance with the CSA, as amended by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing daridorexant in schedule IV, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of such isomers is possible within the specific chemical designation, thereby facilitating the commercial distribution of QUIVIVIQ as a lawful controlled substance.