Qelbree remains the first novel, non-stimulant ADHD medication approved in over a decade and is the only ADHD treatment with serotonin (5-HT2C) pharmacodynamics approved in its FDA product labeling.
Qelbree has provided convenient 24-hour medication exposure for patients with ADHD ages 6 years and older, with approximately 3 million prescriptions filled since launch.
As a non-controlled treatment option, Qelbree has no evidence of abuse potential and is supported by years of clinical and real-world data.
ROCKVILLE, Md., July 14, 2026 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, celebrates the five-year anniversary of the U.S. Food and Drug Administration (FDA) approval of Qelbree (viloxazine extended-release capsules) for attention-deficit/hyperactivity disorder (ADHD). Since its initial approval for pediatric (6 to 17 years) ADHD in April 2021, and subsequent approval for adults in April 2022, Qelbree has served as a valuable option for the nearly 16 million adults and 7 million children and teens living with ADHD in the U.S.,1,2 showcasing Supernus' 25+ year legacy in ADHD research.
Five years after its market introduction, Qelbree offers a once-a-day, non-stimulant option that has been widely adopted in ADHD treatment plans, with approximately 3 million total prescriptions filled since launch and over 1 million prescriptions filled in 2025 alone. Qelbree has given healthcare providers an alternative, backed by clinical and real-world data, for those seeking non-stimulant approaches for help managing ADHD symptoms.
First approved by the FDA for ADHD in pediatric patients 6 to 17 years old, Qelbree was the first novel, non-stimulant approach in ADHD in over a decade. With no evidence of abuse potential, 24-hour exposure, and versatile administration options – including the ability to be sprinkled and to be taken at any time of day – Qelbree offers added flexibility for patients.
Recognizing the evolving understanding of ADHD, with 90% of children continuing to have symptoms into adulthood,3 Supernus secured an expanded indication from the FDA in April 2022 for the treatment of ADHD in adults aged 18 years and older, marking the first non-stimulant treatment option for adults in two decades.
The FDA approved labeling updates for Qelbree in January 2025 to include additional pharmacodynamic data. Today, Qelbree stands out as the first and only non-stimulant ADHD treatment with a multimodal pharmacodynamic profile, meaning it influences important chemical messengers in the brain in different ways. Qelbree takes a differentiated approach by helping to increase norepinephrine and also acting as a partial agonist at the serotonin (5-HT2C) receptor.