Suvorexant, lemborexant and daridorexant proposed for looser control

The Drug Enforcement Administration proposed on August 11, 2026 to move suvorexant, lemborexant, and daridorexant from schedule IV to schedule V of the Controlled Substances Act. The proposal came as a notice of proposed rulemaking published that day [1] — not a final rule; nothing changes yet [1]. The three drugs, sold as the insomnia medications Belsomra, Dayvigo, and Quviviq, remain in schedule IV for now [1].

If the rule is finalised as proposed, the practical difference for anyone handling these drugs is close to nothing. Schedule IV and schedule V carry identical regulatory controls and administrative, civil, and criminal sanctions, so the move down a schedule would not change which controls or sanctions apply [1]. What it would change is the CSA's formal classification. DEA finds that the abuse potential of these three drugs resembles other schedule IV substances, but that they don't produce physical or psychological dependence [1].

The Food and Drug Administration is not aware of any significant diversion from legitimate drug channels, and forensic lab data show 53 reports of suvorexant, one of lemborexant, and one of daridorexant between 2015 and December 2025, across 22 states [1]. The agency's own proposal follows a scientific and medical evaluation and scheduling recommendation that the Department of Health and Human Services sent DEA on December 31, 2025 [1].

For anyone taking one of these medications, none of this changes the drugs' legal status today. That only happens if and when DEA issues a final rule.

What happens next: the docket is open for public comment, and anyone wanting a hearing must request one — both comments and hearing requests are due on or before September 10, 2026 [1].

References

1. Schedules of Controlled Substances: Rescheduling of Suvorexant, Lemborexant, and Daridorexant From Schedule IV Into Schedule V — Federal Register