Dosage and Treatment Protocol for Qelbree (Viloxazine) in ADHD
The recommended dosage for Qelbree (viloxazine extended-release) in ADHD is 100-400 mg once daily for children 6-11 years, 200-400 mg once daily for adolescents 12-17 years, and 200-600 mg once daily for adults, with weekly titration to achieve optimal efficacy and tolerability. 1
Dosing Guidelines by Age Group
Children (6-11 years)
- Starting dose: 100 mg once daily
- Titration: Increase by 100 mg at weekly intervals
- Maximum recommended dose: 400 mg once daily
- Most common effective maintenance dose: 300 mg daily 2
Adolescents (12-17 years)
- Starting dose: 200 mg once daily
- Titration: Increase by 200 mg after 1 week
- Maximum recommended dose: 400 mg once daily
- Most common effective maintenance dose: 400 mg daily 2
Adults
- Starting dose: 200 mg once daily
- Titration: Increase by 200 mg at weekly intervals
- Maximum recommended dose: 600 mg once daily 1
- Most adults (73%) require doses ≥400 mg/day for optimal symptom control 3
Administration Instructions
- Administer orally once daily with or without food
- Capsules should be swallowed whole, not cut, crushed, or chewed
- Alternative administration: Open capsule and sprinkle entire contents over applesauce or pudding
- Consume mixture immediately without chewing
- For pudding: within 15 minutes
- For applesauce: within 2 hours 1
Pre-Treatment Assessment
- Assess heart rate and blood pressure prior to initiating treatment
- Screen for personal or family history of:
- Suicide
- Bipolar disorder
- Depression 1
Monitoring During Treatment
- Reassess heart rate and blood pressure:
- After each dose increase
- Periodically during therapy
- Monitor for emergence of suicidal thoughts and behaviors
- Watch for common side effects:
- In children/adolescents: somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, irritability
- In adults: insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth, constipation 1
Special Populations
Patients with Renal Impairment
- Severe renal impairment (eGFR <30 mL/min/1.73m²):
- Starting dose: 100 mg once daily
- Titration: 50-100 mg weekly increments
- Maximum dose: 200 mg once daily
- No dosage adjustment needed for mild to moderate renal impairment 1
Treatment Duration and Reassessment
- Pharmacological treatment of ADHD may be needed for extended periods
- Periodically reevaluate the long-term use and adjust dosage as needed 1
Important Contraindications
- Concomitant use with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing an MAOI
- Concomitant use with sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range 1
Clinical Efficacy
- Viloxazine ER demonstrates significant improvement in ADHD symptoms compared to placebo, with effects often noticeable by week 2 of treatment 4
- Long-term studies show sustained improvement in ADHD symptoms with continued use 2
- In adults, mean dose at end of study was 504 mg, with significant improvements in attention, hyperactivity/impulsivity, and executive function 4
Safety Considerations
- Black box warning for increased risk of suicidal thoughts and behaviors
- Common adverse events include insomnia, headache, somnolence, decreased appetite, and fatigue
- Most adverse events are mild to moderate in severity
- Discontinuation rates due to adverse events: approximately 8-9% 3, 2
Qelbree represents an effective non-stimulant option for ADHD treatment across all age groups, with dosing that requires careful titration to balance efficacy and tolerability.