Schedules of Controlled Substances: Rescheduling of Suvorexant, Lemborexant, and Daridorexant From Schedule IV Into Schedule V

What it does

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.

The Drug Enforcement Administration's summary, as published in the Federal Register.

What it would change

1 part of Title 21 of the Code of Federal Regulations:

21 CFR 1308

What happens next and when

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.

The agency's dates, word for word.

Check it yourself

• The document in the Federal Register
• Docket DEA-2026-1321 on Regulations.gov
• Title 21 on eCFR

The record as published

Source: the Federal Register (public domain). The document in the Federal Register