Objective: To describe the efficacy and safety of extended-release viloxazine (viloxazine ER; Qelbree) for the treatment of attention-deficit hyperactivity disorder (ADHD) in school-age children and adolescents (6-17 years).
Data sources: A literature search was conducted with PubMed using the following terms: viloxazine and ADHD (August 1, 2017 to February 1, 2023).
Study selection and data extraction: All relevant English-language articles examining the efficacy and safety of viloxazine ER were considered for inclusion.
Data synthesis: Phase III studies reported significant improvement in ADHD symptoms after viloxazine ER treatment in both school-age children (100 mg/d, P = 0.0004 and 200 mg/d, P < 0.0001; NCT03247530) and adolescents (200 mg/d, P = 0.0232; 400 mg/d, P = 0.0091; NCT03247517) compared with placebo. Common adverse effects associated with viloxazine ER included somnolence, fatigue, irritability, decreased appetite, and headache. Together, the studies demonstrated the efficacy and safety of viloxazine ER in patients with ADHD.
Relevance to patient care and clinical practice in comparison with existing drugs: Viloxazine ER is a serotonin-norepinephrine modulator, which is administered once daily orally. It is classified as a nonstimulant medication, which can be used in patients with ADHD who do not respond to or cannot tolerate stimulant medications. Even though atomoxetine and viloxazine ER have not been directly compared, clinical studies have suggested that viloxazine ER has a faster onset of action (~1-2 weeks) compared with atomoxetine (~4 weeks). Like atomoxetine, viloxazine ER carries a boxed warning for suicidal ideation and/or behavior.
Conclusion: Viloxazine ER is a useful addition to other nonstimulant medications available to treat patients with ADHD.
Keywords: ADHD; attention; attention-deficit hyperactivity disorder; cortex; dopamine; hyperactivity; norepinephrine; serotonin; viloxazine.