Is Auvelity a Controlled Substance?
No, Auvelity (dextromethorphan/bupropion) is not a controlled substance. Both dextromethorphan and bupropion, the two components of Auvelity, are explicitly classified as non-controlled substances by the FDA 1.
Regulatory Classification
The FDA drug label for Auvelity clearly states: "AUVELITY contains dextromethorphan and bupropion which are not controlled substances" 1. This means:
- No DEA scheduling: Auvelity does not fall under Schedule I through V of the Controlled Substances Act
- Standard prescribing: No special DEA registration or prescription requirements are needed
- No prescription limits: Unlike controlled substances, there are no federal restrictions on refills or quantity
Abuse Potential Considerations
While not a controlled substance, clinicians should be aware of certain abuse-related considerations:
Dextromethorphan component:
- Cases of dextromethorphan abuse have been reported, predominantly in adolescents 1
- The drug has not been systematically studied for abuse potential
- When combined with bupropion in Auvelity, the clinical studies did not reveal drug-seeking behavior 1
Bupropion component:
- At single doses of 400 mg (approximately 1.9 times the maximum recommended daily dose in Auvelity), bupropion produced mild amphetamine-like activity in individuals experienced with drugs of abuse 1
- However, at recommended divided doses, bupropion is not likely to be significantly reinforcing to people who abuse stimulants 1
- The FDA label notes that higher doses "might be modestly attractive to those who abuse CNS stimulant drugs" 1
Clinical Implications
Monitor patients with substance use history: The FDA label recommends that "patients with a history of drug abuse should be observed closely for signs of AUVELITY misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior)" 1.
Route of administration matters: Auvelity is intended for oral use only. Seizures and/or death have been reported when bupropion has been administered intranasally or by parenteral injection 1.
Practical advantage: Compared with other anti-obesity medications approved since 2012, naltrexone/bupropion (a related combination) is noted as being "neither a controlled substance nor an injectable agent" 2, highlighting the clinical convenience of non-controlled status.
The non-controlled status of Auvelity simplifies prescribing logistics while still requiring appropriate clinical vigilance for potential misuse, particularly in vulnerable populations.