Naltrexone Controlled Substance Status
Naltrexone is NOT a controlled substance and is unscheduled under the Controlled Substances Act, allowing any licensed physician to prescribe it without DEA restrictions. 1
Regulatory Classification
Naltrexone remains unscheduled because it is an opioid antagonist rather than an agonist, meaning it blocks opioid receptors rather than activating them, eliminating abuse potential. 1
This unscheduled status permits decentralized therapeutic approaches and ready prescribing access for motivated patients seeking opioid-free treatment options. 1
Contrast with Combination Products
While naltrexone alone is not controlled, phentermine-topiramate ER is classified as a schedule IV controlled substance due to the phentermine component's potential for abuse and dependence. 2
The naltrexone-bupropion ER combination is not classified as a controlled substance, as neither component has significant abuse potential—naltrexone blocks opioid effects and bupropion lacks the reinforcing properties of schedule IV stimulants. 2, 3
Clinical Implications of Unscheduled Status
The lack of controlled substance classification facilitates broader prescribing access, particularly beneficial for patients in outpatient settings who need separation from drug-using environments. 1
Prescribers do not need DEA registration or special licensing to prescribe naltrexone, unlike methadone or buprenorphine for opioid use disorder. 1
This regulatory advantage makes naltrexone particularly suitable for highly motivated patients preferring opioid-free treatment approaches, including healthcare professionals and criminal justice populations. 3
Important Prescribing Considerations
Despite being unscheduled, naltrexone requires patients to be completely opioid-free for 7-10 days before initiation to avoid precipitating severe withdrawal. 3, 4
Liver function monitoring is recommended at baseline and every 3-6 months, though hepatotoxicity at standard 50 mg doses has not emerged as a clinical problem. 3, 5
The unscheduled status does not eliminate the need for comprehensive addiction treatment—naltrexone works best as part of a larger therapeutic regimen with psychosocial support. 1, 6