Is Qelbree (viloxazine) a Schedule 2 medication?

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Last updated: December 16, 2025View editorial policy

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Qelbree Scheduling Status

No, Qelbree (viloxazine extended-release) is not a Schedule 2 medication—it is a non-controlled, nonstimulant medication without evidence of drug dependence or abuse potential. 1

Key Distinguishing Features

  • Viloxazine functions as a selective norepinephrine reuptake inhibitor with serotonin-norepinephrine modulating properties, representing a nonstimulant treatment option that does not carry the abuse liability associated with Schedule 2 stimulants. 2

  • Unlike CNS stimulants (methylphenidate, amphetamines) which are Schedule 2 controlled substances with high potential for abuse and severe psychological/physical dependence, viloxazine is a non-stimulant medication without evidence of drug dependence. 1

Clinical Implications

  • This non-controlled status makes Qelbree a suitable alternative to standard-of-care stimulant pharmacotherapy for ADHD, particularly for patients where stimulant abuse potential is a concern or where stimulants are contraindicated. 1

  • Prescribers can write standard prescriptions without the restrictions required for Schedule 2 medications (no refills, written prescriptions in many states, quantity limitations). 1

  • The medication was FDA-approved in April 2021 for pediatric ADHD (ages 6-17 years) and subsequently for adults, with its safety profile and pharmacokinetics well understood from its historical use as an antidepressant. 1

Common Pitfall to Avoid

  • Do not confuse the recommendation to consider adding a stimulant medication (which ARE Schedule 2) to existing Qelbree therapy for residual ADHD symptoms with Qelbree's own scheduling status—Qelbree itself remains non-controlled. 3

References

Guideline

Qelbree Mechanism and Efficacy

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Medication Addition to Existing Regimen

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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