Federal Register #DEA-1645

DEA Proposes Rescheduling of Insomnia Medications to Schedule V

This regulatory notice from the Drug Enforcement Administration (DEA), part of the Department of Justice, proposes rescheduling three insomnia medications under the Controlled Substances Act: - Government Buyer: - Drug Enforcement Administration (DEA), Department of Justice - OEMs and Vendors: - Merck & Co., Inc. (Belsomra / suvorexant) - Eisai Co., Ltd. (Dayvigo / lemborexant) - Idorsia Pharmaceuticals Ltd. (Quviviq / daridorexant) - Products/Active Ingredients: - Suvorexant (Belsomra) - Part number: [(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 (Dayvigo) - Part number: (1R,2S)-2-[(2,4-dimethylpyrimidin-5-yl)oxymethyl]-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl)cyclopropane-1-carboxamide - Daridorexant (Quviviq) - Part number: [(2S)-2-(5-chloro-4-methyl-1H-benzimidazol-2-yl)-2-methylpyrrolidin-1-yl]-[5-methoxy-2-(triazol-2-yl)phenyl]methanone - Notable Requirements: - Proposal to move these substances from Schedule IV to Schedule V, reflecting a lower potential for abuse and dependence - Would impose Schedule V regulatory controls and sanctions on all handlers (manufacturers, distributors, researchers, etc.) - Requirements include registration, security, disposal, labeling, inventory, and recordkeeping - No procurement of products or services is requested; this is a regulatory change - The DEA is seeking public comment on this proposed rulemaking

Description

The Drug Enforcement Administration (DEA) proposes to transfer the substances suvorexant, lemborexant, and daridorexant from Schedule IV to Schedule V of the Controlled Substances Act. This proposed rulemaking would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to Schedule V controlled substances on persons who handle or propose to handle these substances. The proposal includes requirements for registration, disposal, security, labeling, inventory, and recordkeeping for these substances. Comments on the proposal must be submitted by September 10, 2026.

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