Viloxazine Extended-Release: A Review in Attention-Deficit/Hyperactivity Disorder in Adults
Viloxazine Extended-Release: A Review in Attention-Deficit/Hyperactivity Disorder in Adults

Viloxazine Extended-Release: A Review in Attention-Deficit/Hyperactivity Disorder in Adults

CNS Drugs. 2025 Oct 22. doi: 10.1007/s40263-025-01227-y. Online ahead of print.

ABSTRACT

An extended-release once-daily oral capsule formulation of viloxazine (viloxazine ER; Qelbree®), a norepinephrine reuptake inhibitor and serotonin receptor modulator, has been approved in the USA for the treatment of attention-deficit/hyperactivity disorder (ADHD) in paediatric patients and adults. This article reviews its use in adults with ADHD, with a brief overview of its pharmacological properties. In a randomized, double-blind, placebo-controlled, 6-week phase 3 trial, viloxazine ER significantly reduced the symptoms and severity of ADHD in adults, and improved executive function. Improvements were observed within 2-3 weeks and were sustained with continued treatment for over 24 months. Viloxazine ER was generally well tolerated in adults, with insomnia and headache being the most common adverse reactions. It has an acceptable safety profile, with no clinically significant cardiovascular or hepatic adverse effects. Current evidence supports viloxazine ER as a valuable addition to the therapeutic options available for adults with ADHD.

PMID:41123831 | DOI:10.1007/s40263-025-01227-y