# 2026-23075: Narcolepsy Drug Joins Schedule IV Despite Its Low Abuse Potential 2026-23075, Schedules of Controlled Substances: Placement of Oveporexton in Schedule IV, is a Federal Register rule from Justice Department, Drug Enforcement Administration published 2026-11-12, effective 2026-11-12; PRIA reads it as touching household money (as of 2026-11-12). - Canonical: https://policyrisk.com/federal-register/2026-23075 - As of: 2026-11-12 - Plain-text twin of the page above; the HTML and this file carry the same facts. ## Facts - Document number: 2026-23075 - Title: Schedules of Controlled Substances: Placement of Oveporexton in Schedule IV - Type: Rule - Agencies: Justice Department; Drug Enforcement Administration - Citation: 91 FR 72775 - Published: 2026-11-12 - Effective: 2026-11-12 - Comments close: 2026-12-14 - Significant: no - Touches household money: yes - Regulation identifier numbers: none - Last updated: 2026-11-12 ## In one line Narcolepsy Drug Joins Schedule IV Despite Its Low Abuse Potential ## Summary Starting November 12, 2026, the drug oveporexton (brand name Orzeyful), used to treat narcolepsy in adults, is officially placed in Schedule IV, meaning it’s recognized as having a low potential for abuse but still controlled by law. This change affects patients, doctors, and pharmacies by adding new rules for prescribing and handling the drug. You’ve got until December 14, 2026, to share your thoughts or request a hearing about this decision. ## Abstract 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. ## Effects PRIA read - Oveporexton placed in Schedule IV: mixed, medium. As of November 12, 2026, the drug oveporexton (brand name Orzeyful) is officially placed in Schedule IV of the Controlled Substances Act, meaning it is recognized as having a low potential for abuse but is legally controlled. FDA approved oveporexton on August 5, 2026, in tablet strengths of 0.5 mg… - Prescriptions subject to controlled-substance rules: mixed, medium. All prescriptions for oveporexton or products containing oveporexton must comply with 21 U.S.C. 829 and be issued in accordance with 21 CFR parts 1306 and 1311, subpart C. The rule also states that patients (end users) who possess oveporexton pursuant to a lawful prescription are not required to re… - DEA registration and handling requirements for businesses: cost, medium. Any person or entity that handles oveporexton (manufacture, distribute, reverse-distribute, dispense, import, export, research, instructional activities, chemical analysis, or possess) must be registered with DEA under 21 U.S.C. 822, 823, 957, and 958 and follow applicable DEA regulations. Registra… ## Related documents - [2026-11526](https://policyrisk.com/federal-register/2026-11526): Implementation of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 201…, 2026-06-09 - [2026-10128](https://policyrisk.com/federal-register/2026-10128): Revision of Applications for Manufacturing and Procurement Quotas, 2026-05-20 - [2025-05007](https://policyrisk.com/federal-register/2025-05007): Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for Veterans Affairs Patients, 2025-03-24 - [2025-02793](https://policyrisk.com/federal-register/2025-02793): Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for Veterans Affairs Patients, 2025-02-19 - [2026-22955](https://policyrisk.com/federal-register/2026-22955): Troy R. Lehman, D.O.; Decision and Order, 2026-11-12 - [2026-22954](https://policyrisk.com/federal-register/2026-22954): Traci B. Lujan, A.P.R.N.; Decision and Order, 2026-11-12 ## Sources - [2026-23075 on federalregister.gov](https://www.federalregister.gov/documents/2026/11/12/2026-23075/schedules-of-controlled-substances-placement-of-oveporexton-in-schedule-iv) - [2026-23075 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-11-12/pdf/2026-23075.pdf) ## Related - [Previous: 2026-23073, Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Depa…](https://policyrisk.com/federal-register/2026-23073) - [Next: C1-2026-21030, AP1000 Design Certification Renewal](https://policyrisk.com/federal-register/C1-2026-21030) - [All Federal Register documents](https://policyrisk.com/federal-register) Source: PRIA, https://policyrisk.com/federal-register/2026-23075 (as of 2026-11-12).