Should Qelbree (viloxazine) be dosed at 100mg twice a day (bid) or 200mg once a day?

Dosing of Qelbree (Viloxazine): Once Daily vs Twice Daily

Qelbree (viloxazine) should be administered as a single daily dose rather than divided into twice daily dosing. 1

FDA-Approved Dosing Recommendations

• The FDA-approved dosing for Qelbree (viloxazine) is specifically indicated as once-daily administration across all age groups: 1

  • Pediatric patients 6-11 years: Starting dose of 100 mg once daily, with titration in increments of 100 mg weekly to maximum 400 mg once daily
  • Pediatric patients 12-17 years: Starting dose of 200 mg once daily, with titration after 1 week by 200 mg to maximum 400 mg once daily
  • Adult patients: Starting dose of 200 mg once daily, with titration in increments of 200 mg weekly to maximum 600 mg once daily

• The extended-release formulation of Qelbree is specifically designed for once-daily administration to maintain therapeutic blood levels throughout a 24-hour period 2

Clinical Evidence Supporting Once-Daily Dosing

• In phase III clinical trials that led to FDA approval, viloxazine extended-release was administered as a once-daily dose, demonstrating significant improvement in ADHD symptoms compared to placebo 3

• Long-term safety and efficacy studies also utilized once-daily dosing regimens, with most adult participants (73%) using doses ≥400 mg/day as a single daily dose 4

• The extended-release formulation was specifically developed to allow for once-daily dosing, which is particularly important for ADHD medications to ensure consistent symptom control throughout the day 2, 5

Adherence Considerations

• Meta-analysis evidence shows that once-daily dosing regimens are associated with significantly higher rates of medication adherence (91.4%) compared to twice-daily regimens (87.1%) 6

• Improved adherence with once-daily dosing is particularly important for chronic conditions requiring long-term medication use, such as ADHD 6

Administration Considerations

• Qelbree capsules may be swallowed whole or opened and the entire contents sprinkled onto applesauce or pudding 1

• For patients with severe renal impairment, the dosing remains once daily but at a lower starting dose (100 mg once daily) with more cautious titration 1

Potential Adverse Effects

• Common adverse effects with once-daily dosing include: 1, 4

  • In pediatric patients: somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability
  • In adult patients: insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth, and constipation

• The once-daily dosing regimen has been shown to be well-tolerated in long-term studies with no new safety concerns emerging over time 4

Clinical Implications

• Dividing the dose into twice-daily administration is not recommended and would deviate from the FDA-approved dosing guidelines 1

• Once-daily dosing simplifies the medication regimen, which may be particularly beneficial for patients with ADHD who may have difficulties with medication adherence 2, 6

• The extended-release formulation was specifically designed to provide consistent drug delivery over 24 hours with a single daily dose 2, 5