Samidorphan: Scheduled Substance No More


The Drug Enforcement Administration has freed this formerly schedule II controlled substance.



The Acting Administrator of the Drug Enforcement Administration has removed samidorphan (3-carboxamido-4-hydroxy naltrexone) and its salts from the schedules of the Controlled Substances Act.1

Samidorphan, a chemical entity that is structurally similar to naltrexone, was a schedule II controlled substance, as it can be derived from opium alkaloids.

One psychiatrist and clinical investigator in favor stated that, “…samidorphan counters weight gain associated with clinical use of olanzapine as antipsychotic medication and this combination product offers significant advancement relative to olanzapine alone…”

Review of scientific and medical evaluations of samidorphan, as well as the recommendation to decontrol samidorphan from the US Department of Health and Human Services, bolstered this decision.

This action effectively removes regulatory controls and any administrative, civil, or criminal sanctions for controlled substances on samidorphan.


1. Drug Enforcement Administration. Schedules of controlled substances: removal of samidorphan from control. Federal Register. April 19, 2021.

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