Schedules of Controlled Substances: Rescheduling of Suvorexant, Lemborexant, and Daridorexant from Schedule IV into Schedule V

What it does

• •Proposes to move three medications (suvorexant, lemborexant, and daridorexant) from Schedule IV to Schedule V of the Controlled Substances Act.
• •Would apply Schedule V regulatory controls, administrative requirements, and criminal/civil sanctions to any person manufacturing, distributing, importing, exporting, researching, or possessing these substances.
• •Establishes a 30-day public comment period ending September 10, 2026, and allows interested parties to request a hearing before the DEA Administrator.

Why it matters

• •These three drugs are FDA-approved insomnia treatments; rescheduling reflects a determination that they have lower abuse potential in Schedule V compared to Schedule IV.
• •The rescheduling will alter regulatory burdens and compliance requirements for pharmaceutical manufacturers, distributors, and researchers handling these medications.

Who is affected

• •Manufacturers, distributors, importers, exporters, and researchers of suvorexant, lemborexant, and daridorexant.
• •Pharmaceutical companies and healthcare entities involved in the supply chain or clinical use of these insomnia medications.
• •Any interested party with standing to comment or request a hearing on the proposal.

What happens next

The DEA will accept written comments and hearing requests through September 10, 2026; the DEA Administrator will decide whether a hearing is necessary and, if so, will designate an Administrative Law Judge to conduct formal proceedings to determine whether the substances meet the statutory criteria for Schedule V placement.