The FDA approved the use of viloxazine (Qelbree) extended-release capsules for adults 18 years of age and older with attention deficit/hyperactivity disorder (ADHD). Qelbree was previously approved for children 6 to 17 years of age with ADHD. The selective norepinephrine reuptake inhibitor is the first nonstimulant ADHD option approved for adults in 20 years.
The medication is taken once a day. It is available in 100-, 150-, and 200-mg oral capsules that can be swallowed whole, or the contents can be sprinkled onto certain foods.
In clinical trials of viloxazine extended-release capsules, participants who took viloxazine experienced a 41% decrease in symptoms, while those who took a placebo had a reduction of 32%. Study participants who received viloxazine also saw improvement in the inattention and hyperactivity/impulsivity AISRS subscale scores. Viloxazine demonstrated no potential for misuse in trials.
The most common adverse effects associated with viloxazine were insomnia, headaches, tiredness, and nausea. Product labeling carries a Boxed Warning about suicidal thoughts. For full prescribing information, consult product labeling.
Qelbree is a product of Supernus Pharmaceuticals.
