Narcolepsy Drug Joins Schedule IV Despite Its Low Abuse Potential
Published Date: 11/12/2026
Rule
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.
Analyzed Economic Effects
3 provisions identified: 0 benefits, 1 costs, 2 mixed.
Oveporexton placed in Schedule IV
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, 1 mg, and 2 mg, with a recommended dose of 1 mg or 2 mg taken orally twice daily (up to 4 mg/day). This scheduling change affects patients, doctors, and pharmacies by adding new legal controls on the drug's handling and distribution starting on that date.
Prescriptions subject to controlled-substance rules
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 register with DEA and are exempt from the registrant security and inventory requirements described for handlers.
DEA registration and handling requirements for businesses
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. Registrants must follow schedule III–V security requirements (21 CFR 1301.71–1301.77), keep labeling and packaging compliant with 21 U.S.C. 825 and 958(e), take an initial inventory when they first handle controlled substances and inventory every two years thereafter, maintain records and reports as required, and comply with disposal rules or surrender/transfer stocks if they are unwilling or unable to register. Unauthorized activities may lead to administrative, civil, or criminal sanctions.
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