Viloxazine

(Qelbree®)

Viloxazine

Drug updated on 5/17/2024

Dosage FormExtended-release capsule (oral; 100 mg, 150 mg, 200 mg)
Drug ClassSelective norepinephrine reuptake inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older.

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.