Drug updated on 3/28/2024
| Dosage Form | Extended-release capsule (oral; 100 mg, 150 mg, 200 mg) |
| Drug Class | Selective norepinephrine reuptake inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older.
Summary
- Viloxazine (Qelbree) is a medication approved for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 years and older.
- A meta-analysis found that viloxazine was significantly superior to placebo in managing ADHD, with more patients showing a 50% reduction in ADHD-Rating Scale-5 scores and improved CGI-I scale results compared to those on placebo.
- However, adverse events were reported significantly more frequently among viloxazine users than among those taking placebos; these included somnolence as well as serious adverse events (SAEs), although the incidence of SAEs was not statistically significant.
- The information above comes from two systematic reviews/meta-analyses focusing on randomized clinical trials involving viloxazine's use for treating ADHD.
- Another review highlighted several novel non-stimulant medications being developed for treating ADHD, including viloxazine; while it suggested these new drugs may offer comparable or better tolerability than stimulants, they are unlikely to show greater efficacy at group level.
- This same review also proposed that some of these new agents could advance pharmacotherapy by targeting etiopathophysiological disruptions specific to certain subgroups of patients with ADHD - moving towards a 'precision medicine' approach rather than 'one size fits all'.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Qelbree (viloxazine) Prescribing Information. | 2022 | Supernus Pharmaceuticals, Inc. Rockville, MD |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Viloxazine for attention-deficit hyperactivity disorder: a systematic review and meta-analysis of randomized clinical trials. | 2022 | Journal of Central Nervous System Disease |
| Beyond stimulants: a systematic review of randomised controlled trials assessing novel compounds for ADHD. | 2019 | Expert Review of Neurotherapeutics |