DEA Reschedules Sleep Drugs Suvorexant, Lemborexant, Daridorexant to Chill Schedule V
Published Date: 8/11/2026
Proposed Rule
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.
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
DEA proposes rescheduling three insomnia drugs
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) would be subject to the regulatory controls and the administrative, civil, and criminal sanctions applicable to Schedule V controlled substances. Public comments and hearing requests must be submitted or postmarked on or before September 10, 2026.
Handlers must meet Schedule V obligations
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 rules, inventories, records and reports, prescription requirements, and import/export controls. Activities not authorized under the CSA would be unlawful and may result in administrative, civil, or criminal liability.
Patients with prescriptions not subject to registrant rules
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 register with DEA or follow those registrant-specific handling rules.
DEA certifies no economic impact on small entities
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 therefore projects no economic impact on entities that handle these substances, including small entities.
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Key Dates
Department and Agencies
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