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

<p dir="ltr"><b>Declarations</b></p><p dir="ltr"><b>Funding</b> The preparation of this review was not supported by any external funding.</p><p dir="ltr"><b>Authorship and Conflict of interest</b> Yahiya Y. Syed is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.</p><p><br></p><p dir="ltr"><b>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability</b> not applicable</p><p><br></p><p dir="ltr">Additional information about this Adis Drug Review can be found <a href="https://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews" target="_blank">here</a></p><p><br></p><p dir="ltr"><b>Abstract</b></p><p dir="ltr">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, with the most common adverse reactions in adults being insomnia and headache. 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.</p><p><br></p><p dir="ltr">© Springer Nature Switzerland AG 2025</p>