DEA Proposes Rescheduling Suvorexant, Lemborexant, and Daridorexant to Schedule V

What this means for your practice

For telehealth brands, medspas, dental practices, chiropractic offices, and other healthcare businesses, this proposed rescheduling action carries important compliance implications. While a move from Schedule IV to Schedule V generally signifies a lower potential for abuse, it does not remove these substances from controlled status. Practitioners prescribing, dispensing, or administering suvorexant, lemborexant, or daridorexant must ensure their operational protocols and electronic health record (EHR) systems are updated to reflect the new scheduling requirements, should the rule be finalized. This includes proper storage, recordkeeping, inventory, and dispensing procedures in accordance with Schedule V regulations. Failure to comply could result in administrative, civil, and even criminal sanctions. It is crucial for all relevant healthcare providers to monitor the finalization of this rule and adjust their compliance frameworks accordingly.

WASHINGTON, D.C. — The Drug Enforcement Administration (DEA) has announced a notice of proposed rulemaking to reschedule suvorexant, lemborexant, and daridorexant from Schedule IV to Schedule V of the Controlled Substances Act (CSA). This action, if finalized, would modify the regulatory oversight for these medications, impacting all persons and entities involved in their handling, from manufacturing to patient possession.

Overview of the Proposed Rule

The DEA's proposed rule, published in the Federal Register, aims to reclassify suvorexant ([(7 R )-4-(5-chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-yl]-[5-methyl-2-(triazol-2-yl)phenyl]methanone), lemborexant ((1 R, 2 S )-2-[(2,4-dimethylpyrimidin-5-yl)oxymethyl]-2-(3-fluorophenyl)- N -(5-fluoropyridin-2-yl)cyclopropane-1-carboxamide), and daridorexant ([(2 S )-2-(5-chloro-4-methyl-1 H -benzimidazol-2-yl)-2-methylpyrrolidin-1-yl]-[5-methoxy-2-(triazol-2-yl)phenyl]methanone). Currently, these substances are classified under Schedule IV of the CSA. The proposal seeks to transfer them to Schedule V.

What Does Rescheduling Mean?

Controlled substances are categorized into five schedules based on their potential for abuse, accepted medical use, and safety or dependence liability. Schedule I drugs have the highest potential for abuse and no accepted medical use, while Schedule V drugs have the lowest potential for abuse among scheduled substances.

The proposed transfer of suvorexant, lemborexant, and daridorexant from Schedule IV to Schedule V signifies a determination by the DEA that these substances may present a slightly lower potential for abuse compared to other Schedule IV substances. However, it is critical to understand that even as Schedule V substances, they remain subject to stringent regulatory controls.

If this rule is finalized, individuals and entities that manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess these substances would be required to comply with the regulatory controls and administrative, civil, and criminal sanctions applicable to Schedule V controlled substances. This includes specific requirements for registration, recordkeeping, inventory, security, and prescribing practices.

Opportunities for Public Comment and Hearings

The DEA is accepting public comments on this proposed rulemaking. Interested persons are encouraged to submit their feedback, electronically or via mail, on or before September 10, 2026. Electronic comments can be submitted through the Federal eRulemaking Portal at www.regulations.gov. When submitting comments, it is essential to reference “Docket No. DEA-1645” to ensure proper handling.

In addition to written comments, interested parties may also file a request for a hearing or a waiver of hearing. Such requests must be submitted in accordance with 21 CFR 1308.44, 21 CFR 1316.47, and/or 1316.49, as applicable. Requests for a hearing, along with a written statement detailing the factual and legal position asserted, must also be received or postmarked by September 10, 2026.

The DEA emphasizes that all comments received will be considered part of the public record and will be available for public inspection online at www.regulations.gov, unless reasonable cause is provided to withhold specific information.

Key Facts

| Detail | Value | |---|---| | Agency | Drug Enforcement Administration, Department of Justice | | Action | Notice of proposed rulemaking | | Affected Substances | Suvorexant, lemborexant, and daridorexant | | Proposed Change | Transfer from Schedule IV to Schedule V of the Controlled Substances Act | | Comment and Hearing Request Deadline | September 10, 2026 | | Docket Number | DEA-1645 |

Frequently Asked Questions

Which substances are part of this proposed rescheduling by the DEA?

The proposed rule affects suvorexant, lemborexant, and daridorexant.

What is the DEA proposing to do with these substances?

The DEA proposes to transfer these substances from Schedule IV to Schedule V of the Controlled Substances Act (CSA).

If finalized, what would be the impact on handling these substances?

If finalized, persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) these substances would be subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to Schedule V controlled substances.

What is the deadline to submit comments or request a hearing on this proposal?

Comments and requests for a hearing or waiver of hearing must be submitted or postmarked on or before September 10, 2026.

How can I submit comments on this proposed rule?

Comments can be submitted electronically through the Federal eRulemaking Portal at www.regulations.gov, or via regular or express mail to the Drug Enforcement Administration.

Source: DEA — Proposed Rule: Schedules of Controlled Substances: Rescheduling of Suvorexant, Lemborexant, and Daridorexant From Schedule IV Into Schedule V · 2026-08-11