Maximum Dose of Qelbree (Viloxazine Extended-Release)
The maximum recommended dose of Qelbree is 600 mg once daily for adults and 400 mg once daily for pediatric patients (ages 6-17 years). 1
Dosing by Age Group
Adults (18+ years)
- Maximum dose: 600 mg once daily 1
- Starting dose: 200 mg once daily 1
- Titration: Increase by 200 mg increments weekly based on response and tolerability 1
Adolescents (12-17 years)
- Maximum dose: 400 mg once daily 1
- Starting dose: 200 mg once daily 1
- Titration: After 1 week, may increase by 200 mg to reach maximum dose 1
Children (6-11 years)
- Maximum dose: 400 mg once daily 1
- Starting dose: 100 mg once daily 1
- Titration: Increase by 100 mg increments at weekly intervals 1
Special Population: Severe Renal Impairment
For patients with severe renal impairment (eGFR < 30 mL/min/1.73m²):
- Maximum dose: 200 mg once daily 1
- Starting dose: 100 mg once daily 1
- Titration: 50-100 mg increments weekly 1
This represents a significant dose reduction compared to the general population, as severe renal impairment affects viloxazine clearance 1.
Clinical Context from Guidelines
The American Journal of Obstetrics and Gynecology guidelines confirm the 600 mg/day maximum dose for adults, noting this medication has limited efficacy data in adult populations 2. The guidelines emphasize weekly titration by 200 mg increments based on response and tolerability 2.
Real-World Dosing Patterns
In clinical practice, most adult patients (73%) used doses ≥400 mg/day during long-term maintenance treatment, with 36% requiring the full 600 mg/day maximum dose 3. The mean dose in adult trials was approximately 504 mg/day 4. For pediatric patients, median modal doses were 300 mg/day for children and 400 mg/day for adolescents during long-term treatment 5.
Important Caveats
- Do not exceed these maximum doses as overdose cases (up to 10.8 times the maximum recommended dose) have been reported with drowsiness, impaired consciousness, and increased heart rate 1
- No dose adjustment is needed for mild to moderate renal impairment (eGFR 30-89 mL/min/1.73m²) 1
- Doses above 400 mg may not provide additional efficacy benefit based on dose-response analysis showing a bell-shaped curve 6