On March 2, 2026, the U.S. Drug Enforcement Administration (DEA) issued a final rule officially placing five synthetic benzodiazepine substances in Schedule I of the Controlled Substances Act. The rule will take effect on April 1, 2026.
Substances Involved
- Clonazolam
- Diclazepam
- Etizolam
- Flualprazolam
- Flubromazolam
Background
These substances were temporarily placed in Schedule I on July 26, 2023, with an original expiration date of July 26, 2025, which was subsequently extended to July 26, 2026. This final rule makes their placement permanent.
DEA's Determination
The DEA determined that these substances meet the criteria for Schedule I controlled substances:
- High potential for abuse: Pharmacologically similar to traditional benzodiazepines (such as diazepam/Valium), capable of producing dependence
- No currently accepted medical use in the United States: Although Etizolam is approved for treating anxiety and insomnia in India, Italy, and Japan, the U.S. Department of Health and Human Services (HHS) has determined that it lacks accepted medical use in the United States
- Lack of accepted safety for use under medical supervision
Regulatory Impact
Placement in Schedule I means these substances will be subject to the strictest regulatory controls, including:
- Licensing required for manufacturing, distribution, and reverse distribution
- Strict limitations on importation and exportation
- Compliance with Schedule I regulations for possession, research, and educational activities
- Applicable administrative, civil, and criminal sanctions for Schedule I substances
Notably, these are the first benzodiazepines to be placed in Schedule I, while other common benzodiazepines (such as alprazolam/Xanax, diazepam/Valium, and lorazepam/Ativan) remain in the less restrictive Schedule IV.
