Qelbree (Viloxazine ER) Dosing for ADHD
Start Qelbree at 100 mg once daily for children 6-11 years, 200 mg once daily for adolescents 12-17 years and adults, titrating weekly by 100-200 mg increments based on age to maximum doses of 400 mg (children), 400 mg (adolescents), or 600 mg (adults) once daily. 1
Pediatric Dosing (Ages 6-17 Years)
Children 6-11 Years
- Starting dose: 100 mg orally once daily 1
- Titration schedule: Increase by 100 mg increments at weekly intervals based on response and tolerability 1
- Maximum dose: 400 mg once daily 1
Adolescents 12-17 Years
- Starting dose: 200 mg orally once daily 1
- Titration schedule: After 1 week, may increase by 200 mg increment to maximum dose 1
- Maximum dose: 400 mg once daily 1
Adult Dosing (Ages 18-65 Years)
- Starting dose: 200 mg orally once daily 1
- Titration schedule: Increase by 200 mg increments weekly based on response and tolerability 1
- Maximum dose: 600 mg once daily 1
- Optimal maintenance dosing: In long-term studies, 73% of adults used doses ≥400 mg/day during maintenance, with 36% requiring the maximum 600 mg/day dose 2
Administration Guidelines
- Timing: Administer once daily in the morning for optimal symptom control throughout the day 3, 1
- Food: May be taken with or without food 1
- Capsule administration: Swallow whole, OR open capsule and sprinkle entire contents on pudding (consume within 15 minutes) or applesauce (consume within 2 hours) 1
- Do NOT: Cut, crush, or chew capsules 1
Special Population: Severe Renal Impairment
For patients with eGFR <30 mL/min/1.73m²:
- Starting dose: 100 mg once daily 1
- Titration: Increase by 50-100 mg increments weekly 1
- Maximum dose: 200 mg once daily 1
- No adjustment needed for mild-moderate renal impairment (eGFR 30-89 mL/min/1.73m²) 1
Critical Monitoring Requirements
Before Initiating Treatment
- Cardiovascular assessment: Measure heart rate and blood pressure 1
- Psychiatric screening: Assess personal/family history of suicide, bipolar disorder, and depression 1
During Treatment
- Reassess vital signs: Following each dose increase and periodically during maintenance 1
- Suicidality monitoring: Closely monitor for emergence of suicidal thoughts/behaviors, particularly early in treatment 1
Timeline for Therapeutic Response
- Initial response: Therapeutic effects may not be observed until 2-4 weeks after initiation 3
- Early response prediction: Improvement in ADHD-RS total score at week 2 predicts week 6 response with 75% positive predictive power 4
- Sustained improvement: Long-term studies demonstrate continued symptom improvement, with mean ADHD-RS reductions of -24.3 at month 3, -26.1 at month 12, and -22.4 at last visit 5
Common Pitfalls and Caveats
Dosing Errors to Avoid
- Insufficient titration time: Allow at least 1 week between dose increases to assess response and tolerability 1
- Premature discontinuation: Therapeutic effects require 2-4 weeks; avoid stopping before adequate trial duration 3
- Inadequate final dosing: Most adults require ≥400 mg/day for optimal response; don't hesitate to titrate to maximum doses if tolerated 2
Safety Considerations
- Most common adverse events (≥5%):
- Discontinuation rates: 8.2% in pediatric long-term studies and 17.6% in adult long-term studies due to adverse events 5, 2
- Somnolence warning: Advise patients about potential sedation affecting ability to drive or operate machinery 1
Contraindications
- Absolute contraindications:
- Drug interactions: Not recommended with moderate sensitive CYP1A2 substrates; dose reduction may be warranted 1
Special Populations
- Limited adult efficacy data: Viloxazine has limited data on efficacy for ADHD treatment in adults compared to pediatric populations 6
- Pregnancy/breastfeeding: No published safety data; alternative agents preferred; may cause maternal harm and should be discontinued when pregnancy recognized 6, 1
- Long-term use: Periodically reevaluate need for continued treatment and adjust dosage as needed 1