Final rule · 2026-23075

Schedules of Controlled Substances: Placement of Oveporexton in Schedule IV

On August 5, 2026, the United States Food and Drug Administration (FDA) approved a new drug application for Orzeyful (oveporexton) for the treatment of narcolepsy type 1 in adults. The Department of Health and Human Services (HHS) provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place oveporexton, chemically known as N-[(2S,3R)-2-[[3-(3,5- difluorophenyl)-2-fluorophenyl]methyl]-4,4-difluoro-1-(2-hydroxy-2- methylpropanoyl)pyrrolidin-3-yl]ethanesulfonamide, 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 oveporexton, 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.