Summary

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• Viloxazine (Qelbree) is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older. It has demonstrated superiority over placebo in managing ADHD symptoms, based on results from five randomized controlled trials involving a total of 1605 pediatric patients.
• Three systematic reviews/meta-analyses were analyzed, providing insights into Qelbree's safety, efficacy, and comparison with other ADHD treatments, primarily focusing on the pediatric population.
• Although viloxazine does not directly compare with other ADHD medications such as stimulants, it offers an alternative for individuals seeking non-stimulant options or who have poor tolerance to stimulants.
• Adverse events were more common in patients treated with viloxazine compared to placebo; however, serious adverse events were not statistically significantly higher, indicating a manageable safety profile within the observed research duration.
• Subgroup analyses indicated that both children and adolescents showed better efficacy than placebo, with a consistent safety profile across different age groups within the pediatric population, despite a significantly higher risk of adverse events but not serious ones.
• Although the focus was primarily on pediatric use, the findings suggest potential benefits for adult patients, warranting further investigation given its non-stimulant nature and efficacy profile.