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Supernus Celebrates Five-Year Anniversary of Qelbree® FDA Approval, Continuing to Deliver on Real-World Experience in ADHD

SUPN
  • Supernus Pharmaceuticals celebrated the five-year anniversary of FDA approval for Qelbree (viloxazine extended-release capsules) for treating ADHD in patients aged 6 years and older.
  • Qelbree was the first novel, non-stimulant ADHD medication approved in over a decade for pediatrics (April 2021) and the first non-stimulant option for adults in two decades (April 2022).
  • Approximately 3 million prescriptions have been filled since launch, with over 1 million filled in 2025 alone.
  • The medication offers 24-hour exposure, has no evidence of abuse potential, is not a controlled substance, and can be taken once daily at any time of day or sprinkled.
  • January 2025 FDA labeling updates established Qelbree as the only non-stimulant ADHD treatment with a multimodal pharmacodynamic profile, acting on norepinephrine and as a partial agonist at the serotonin (5-HT 2C) receptor.
  • Qelbree became the first ADHD treatment to include lactation data in its labeling following 2019 FDA guidance on clinical lactation studies.
  • The drug is indicated for nearly 16 million adults and 7 million children/teens in the U.S. with ADHD.
  • Important safety warnings include an increased risk of suicidal thoughts, potential increases in blood pressure and heart rate, risk of manic episodes in bipolar disorder patients, and possible drowsiness affecting driving or machinery operation.
  • Common side effects include sleepiness, fatigue, decreased appetite, nausea, vomiting, insomnia, headache, dry mouth, constipation, and irritability.
  • Qelbree is available in 100 mg, 150 mg, and 200 mg capsule strengths.