Schedules of Controlled Substances: Placement of Oveporexton in Schedule IV

What it does

• •Places oveporexton (Orzeyful), a new drug approved by FDA on August 5, 2026 for treating narcolepsy type 1 in adults, into Schedule IV of the Controlled Substances Act.
• •The rule covers oveporexton in all its forms, including salts, isomers, and salts of isomers.
• •Issues an interim final rule effective November 12, 2026, with a 30-day public comment period ending December 14, 2026.

Why it matters

• •Oveporexton has CNS activity as an orexin type 2 receptor agonist with identified abuse potential, requiring federal scheduling to allow regulated medical use while preventing misuse.
• •The expedited 90-day scheduling process mandated by the Improving Regulatory Transparency for New Medical Therapies Act (2015) enables the new drug to reach patients without undue delay while establishing appropriate legal controls.

Who is affected

• •Healthcare providers prescribing oveporexton and patients with narcolepsy type 1 seeking this treatment.
• •Pharmaceutical manufacturers, distributors, and pharmacies handling the controlled substance.
• •The general public through the opportunity to submit comments on the scheduling determination.

What happens next

The DEA will accept public comments and hearing requests through December 14, 2026, and the Administrator will determine whether a hearing is necessary; if so, the DEA will publish a notice of hearing and issue a final rule following statutory scheduling criteria.