DEA Proposes Rescheduling DORAs for Insomnia Treatment
The US Drug Enforcement Administration (DEA) has proposed transferring three dual orexin receptor antagonists (DORAs) from Schedule IV to Schedule V of the Controlled Substances Act.
## DEA Proposes Rescheduling DORAs for Insomnia Treatment The US Drug Enforcement Administration (DEA) has published a proposed rule to transfer three dual orexin receptor antagonists (DORAs) from Schedule IV to Schedule V of the Controlled Substances Act. This move would affect the medications suvorexant, lemborexant, and daridorexant, which are used to treat insomnia. ## Lower Abuse Potential and Dependence According to the DEA's notice, the proposed reclassification follows a scientific and medical evaluation by the Department of Health and Human Services. The evaluation indicates that these Food and Drug Administration-approved insomnia treatments have a low potential for abuse relative to Schedule IV substances and do not produce physical or psychological dependence. This conclusion is based on recent epidemiological data and evaluations of the drugs' market presence, which show low rates of abuse and misuse compared to other Schedule IV sedative-hypnotics. ## Manufacturer Supports Proposal Idorsia Ltd, the manufacturer of daridorexant, has acknowledged the proposal and plans to submit comments during the open period. The company views the recommendation to reclassify to the least restrictive Schedule V as an important first step. Idorsia's chairman and interim CEO, Jean-Paul Clozel, MD, stated that the proposed reclassification recognizes the favorable profile of daridorexant compared with traditional sedative-hypnotics. While the company believes that the available evidence supports full descheduling, they will analyze the proposal in detail and provide comments through the appropriate forum. ## Public Comment Period Open The DEA is accepting public comments on the proposed rule until September 10, 2026, before issuing a final decision. If finalized, the substances would be subject to the regulatory controls and sanctions applicable to Schedule V controlled substances, which involve less restrictive handling and prescribing requirements than Schedule IV. This change could improve patient access to the DORA class of medications, according to Idorsia.
