Data / Federal rules / 2026-16375
Schedules of Controlled Substances: Rescheduling of Suvorexant, Lemborexant, and Daridorexant From Schedule IV Into Schedule V
The Drug Enforcement Administration published this proposed rule in the Federal Register on August 11, 2026. Comments closed on September 10, 2026.
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What the agency says
The Drug Enforcement Administration proposes to transfer suvorexant ([(7R)-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4- diazepan-1-yl]-[5-methyl-2-(triazol-2-yl)phenyl]methanone), lemborexant ((1R,2S)-2-[(2,4-dimethylpyrimidin-5-yl)oxymethyl]-2-(3-fluorophenyl)- N-(5-fluoropyridin-2-yl)cyclopropane-1-carboxamide), and daridorexant ([(2S)-2-(5-chloro-4-methyl-1H-benzimidazol-2-yl)-2-methylpyrrolidin-1- yl]-[5-methoxy-2-(triazol-2-yl)phenyl]methanone) from schedule IV to schedule V of the Controlled Substances Act. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule V controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle suvorexant, lemborexant, and daridorexant.
Key facts
- Document number
- 2026-16375
- Type
- Proposed rule
- Action
- Notice of proposed rulemaking
- Agency
- Justice Department; Drug Enforcement Administration
- Published
- August 11, 2026
- Comments due
- September 10, 2026
- Dates
- Comments must be submitted electronically or postmarked on or before September 10, 2026. The electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.
- Docket
- Docket No. DEA-1645
- Code of Federal Regulations
- 21 CFR 1308
- Topics
- Administrative practice and procedure; Drug traffic control; Reporting and recordkeeping requirements
- Pages
- 6
Other documents from the Drug Enforcement Administration
Everything from the Drug Enforcement Administration · Rules on administrative practice and procedure · Rules on drug traffic control · Rules on reporting and recordkeeping requirements · Published in August 2026
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.