# 2026-16375: DEA Reschedules Sleep Drugs Suvorexant, Lemborexant, Daridorexant to Chill Schedule V

2026-16375, Schedules of Controlled Substances: Rescheduling of Suvorexant, Lemborexant, and Daridorexant From Schedule IV Into Schedule V, is a Federal Register proposed rule from Justice Department, Drug Enforcement Administration published 2026-08-11, effective 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.; PRIA reads it as touching household money (as of 2026-08-18).

- Canonical: https://policyrisk.com/federal-register/2026-16375
- As of: 2026-08-18
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-16375
- Title: Schedules of Controlled Substances: Rescheduling of Suvorexant, Lemborexant, and Daridorexant From Schedule IV Into Schedule V
- Type: Proposed Rule
- Agencies: Justice Department; Drug Enforcement Administration
- Citation: 91 FR 51606
- Published: 2026-08-11
- Effective: 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.
- Comments close: 2026-09-10
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-08-18

## In one line

DEA Reschedules Sleep Drugs Suvorexant, Lemborexant, Daridorexant to Chill Schedule V

## Summary

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.

## Effects PRIA read

- DEA proposes rescheduling three insomnia drugs: cost, low. DEA proposes to transfer suvorexant (Belsomra), lemborexant (Dayvigo), and daridorexant (Quviviq) from Schedule IV to Schedule V of the Controlled Substances Act. If finalized, persons who handle or propose to handle these substances (manufacture, distribute, research, import/export, or possess) wo…
- Handlers must meet Schedule V obligations: cost, low. If the rescheduling is finalized, registrants who handle suvorexant, lemborexant, or daridorexant must comply with Schedule V requirements including DEA registration, disposal of stocks under 21 CFR part 1317 if they do not maintain registration, Schedule V security rules, labeling and packaging ru…
- Patients with prescriptions not subject to registrant rules: benefit, low. The proposal states that registration, security, inventory, and certain other registrant requirements do not apply to patients (ultimate users) who possess suvorexant, lemborexant, or daridorexant pursuant to a lawful prescription. In other words, lawful prescription holders are not required to reg…
- DEA certifies no economic impact on small entities: benefit, low. Under the Regulatory Flexibility Act, DEA certifies that transferring these substances from Schedule IV to Schedule V "will not have a significant economic impact on a substantial number of small entities" because the regulatory controls and sanctions are the same under both schedules. DEA therefor…

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## Sources
- [2026-16375 on federalregister.gov](https://www.federalregister.gov/documents/2026/08/11/2026-16375/schedules-of-controlled-substances-rescheduling-of-suvorexant-lemborexant-and-daridorexant-from)
- [2026-16375 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-08-11/pdf/2026-16375.pdf)

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Source: PRIA, https://policyrisk.com/federal-register/2026-16375 (as of 2026-08-18).