Federal Register #DEA-2026-1321

DEA Proposes Rescheduling of Insomnia Drugs Suvorexant, Lemborexant, and Daridorexant

This opportunity concerns a proposed regulatory change by the Drug Enforcement Administration (DEA), part of the Department of Justice, regarding certain insomnia medications: - 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 Affected: - 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: - This is a regulatory action, not a procurement; no purchase quantities or direct product acquisition is involved - The proposal would move these drugs from Schedule IV to Schedule V under the Controlled Substances Act - Entities handling these substances (manufacturers, distributors, importers, exporters, researchers, and possessors) would be subject to Schedule V regulatory controls and sanctions - The change is based on scientific and medical evaluations indicating lower abuse potential and dependence risk - Compliance with new regulatory requirements would be mandatory if the rule is finalized

Description

The Drug Enforcement Administration (DEA) proposes to transfer suvorexant, lemborexant, and daridorexant from schedule IV to schedule V of the Controlled Substances Act. This proposed rulemaking would impose the regulatory controls and sanctions applicable to schedule V controlled substances on persons who handle these substances, including manufacture, distribution, import, export, research, and possession. Comments on the proposal must be submitted by September 10, 2026. The proposal is part of DEA's regulatory process to update controlled substance schedules based on scientific and medical evaluations.

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