Qelbree FDA Approval History
FDA Approved: Yes (First approved April 2, 2021)
Brand name: Qelbree
Generic name: viloxazine hydrochloride
Dosage form: Extended Release Capsules
Company: Supernus Pharmaceuticals, Inc.
Treatment for: ADHD
Qelbree (viloxazine hydrochloride) is a serotonin norepinephrine modulating agent (SNMA) for the treatment of attention deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age.
- Qelbree is a non-stimulant, and it is not a controlled substance.
- Qelbree capsules are taken once daily.
- Qelbree may increase suicidal thoughts and actions in some children with ADHD, especially within the first few months of treatment or when the dose is changed. Patients should be carefully monitored, and any new or sudden changes in mood or behavior should be reported to the child’s doctor right away.
- Common side effects include somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability.
Development Timeline for Qelbree
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.