Schedules of Controlled Substances: Placement of Lemborexant in Schedule IV

On December 20, 2019, the U.S. Food and Drug Administration approved a new drug application for Dayvigo (lemborexant) tablets for oral use. Lemborexant is chemically known as (1R,2S)-2-[(2,4- dimethylpyrimidin-5-yl)oxymethyl]-2-(3-fluorophenyl)-N-(5- fluoropyridin-2-yl)cyclopropane-1-carboxamide. The Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place lemborexant 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 lemborexant, 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.