Recommended Formulation of Viloxazine for ADHD Treatment
Viloxazine extended-release (Qelbree) is the recommended formulation for ADHD treatment, administered as a once-daily oral dose in the morning. 1, 2
Dosing Recommendations
Pediatric Patients (6-17 years)
- For children 6-11 years: Start with 100 mg once daily, may titrate in increments of 100 mg weekly to maximum recommended dosage of 400 mg once daily 2
- For adolescents 12-17 years: Start with 200 mg once daily, may titrate after 1 week by an increment of 200 mg to maximum recommended dosage of 400 mg once daily 2
Adult Patients
- Start with 200 mg once daily, may titrate in increments of 200 mg weekly to maximum recommended dosage of 600 mg once daily 2
Administration Options
- Capsules may be swallowed whole OR opened and entire contents sprinkled onto applesauce or pudding 2
- Morning administration is preferred for optimal management of ADHD symptoms with minimal adverse effects, providing "around-the-clock" symptom control 1
- Sprinkling contents on applesauce decreases viloxazine Cmax and AUC by about 10% and 5% respectively, but this is not clinically significant 2
Special Populations
- For patients with severe renal impairment (eGFR <30 mL/min/1.73m²): Initial dosage is 100 mg once daily, titrate in weekly increments of 50 mg to 100 mg to maximum recommended dosage of 200 mg once daily 2
- No dosage adjustment needed for patients with mild to moderate renal impairment 2
- Limited data available on efficacy and safety in adults, and no published information on safety during pregnancy or breastfeeding 3, 4
Pharmacological Properties
- Viloxazine is a selective norepinephrine reuptake inhibitor (SNRI) 2
- Extended-release formulation allows for once-daily dosing 2, 5
- Steady-state is reached after two days of once-daily administration with no accumulation observed 2
- Mean half-life is approximately 7 hours 2
Clinical Considerations
- Treatment effects are not usually observed until several weeks (2-4 weeks) after initiation 1
- Monitor for potential adverse effects including somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability in pediatric patients 2
- In adults, common adverse effects include insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth, and constipation 2
- Closely monitor for worsening and emergence of suicidal thoughts and behaviors, especially during initial treatment period 2
Timing Considerations
- Recent research suggests that viloxazine ER can be administered either in the morning or evening with similar efficacy and safety profiles 6
- However, the FDA label and clinical guidelines still recommend morning administration as the standard approach 1, 2