FDA Approves First Nonstimulant ADHD Drug for Adults in 20 Years

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May 2, 2022 – Supernus Pharmaceuticals’ Qelbree® (viloxazine extended-release capsules) has received an expanded indication to treat attention deficit hyperactivity disorder (ADHD) in adults as well as in pediatric patients six years old and up.

  • The U.S. FDA originally approved Qelbree in 2021 to treat ADHD in patients 6-17 years of age. The drug is the first new nonstimulant ADHD treatment to receive FDA approval for adults since 2002.
  • Recommended dosing is:
    • Patients 6-11 years old: 100mg once daily to start, with the option to titrate in increments of 100 g weekly to a maximum recommended dose of 400mg once daily.
    • Patients 12-17 years old: 200mg once daily, with the option to increase the dosage by 200mg after one week to the maximum recommended dose of 400mg once daily.
    • Patients 18 years old and up: 200mg once daily, with the option to titrate in increments of 200mg weekly to a maximum recommended dose of 600mg once daily.