From the Guidelines
Viloxazine ER (Qelbree) should be dosed starting at 200 mg orally once daily, with titration by 200 mg increments at weekly intervals based on response and tolerability, up to a maximum daily dose of 600 mg/d. This dosing recommendation is based on the most recent evidence available, as reported in the study by Scoten 1. The study provides guidance on the treatment of attention-deficit/hyperactivity disorder (ADHD) in pregnancy and the postpartum period, including the use of viloxazine.
Key Considerations
- The medication is approved in the United States for treatment in children and adolescents aged 6 and older, but its availability and approval may vary by jurisdiction 1.
- There are no published studies of viloxazine in pregnancy, and alternative agents may be preferred due to the limited data on its efficacy for the treatment of ADHD in adults 1.
- Patients should be closely monitored for side effects, particularly during dose adjustments, as viloxazine can cause common side effects such as somnolence, headache, decreased appetite, and irritability.
Dosing Adjustments
- Dose adjustments should occur weekly, allowing time to assess response and side effects.
- Patients with severe renal impairment may require lower doses, although specific guidance on dosing in renal impairment is not provided in the study 1.
Important Warnings
- Viloxazine carries a risk of suicidal thoughts in children and adolescents, and close monitoring is essential, especially during dose adjustments 1.
From the Research
Viloxazine Dosing
- The optimal dosing of viloxazine for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) is a subject of ongoing research 2.
- A meta-analysis of five dose-response randomized clinical trials found that viloxazine was associated with better outcomes in ADHD treatment compared with placebo, with a mean difference of 5.47 points on the ADHD Rating Scale-5 2.
- The same study suggested that a moderate dose of 200-400 mg or 6-8 mg/kg may provide optimal treatment outcomes, as the dose-response curve was bell-shaped, indicating that higher doses may not be associated with greater efficacy 2.
- A phase 2 study found that once-daily dosing of viloxazine ER in 200,300, or 400 mg dosages in children with ADHD for eight weeks resulted in a statistically significant reduction of ADHD-RS-IV total score 3.
- The FDA has approved viloxazine ER for the treatment of ADHD in children aged 6-17, with a recommended dosing regimen that is not specified in the provided studies 4, 3.
Dosing Considerations
- The temporal trends analysis of the meta-analysis showed that the treatment response to viloxazine was rapid, with significant improvements in ADHD symptoms observed at week 2, and the response curve tapering off at approximately weeks 4 to 6 2.
- The study also found that the overall discontinuation rate due to adverse effects was 4.15% in the viloxazine group, and that viloxazine was associated with a 2.48-fold higher risk of discontinuation due to adverse effects compared with placebo 2.
- The safety profile and pharmacokinetics of viloxazine are well understood, given its long-standing use as an antidepressant, and it appears to be a suitable alternative to current standard-of-care pharmacotherapy for ADHD 4.