Maximum Recommended Dosage of Qelbree (Viloxazine)
The maximum recommended dosage of Qelbree (viloxazine) is 400 mg once daily for pediatric patients (6-17 years) and 600 mg once daily for adults. 1
Age-Specific Dosing Guidelines
Children (6-11 years)
- Starting dose: 100 mg once daily
- Titration: Increase by 100 mg at weekly intervals
- Maximum dose: 400 mg once daily
- Median modal (most frequently used) dose in long-term studies: 300 mg/day 2
Adolescents (12-17 years)
- Starting dose: 200 mg once daily
- Titration: Increase by 200 mg after 1 week
- Maximum dose: 400 mg once daily
- Median modal dose in long-term studies: 400 mg/day 2
Adults
- Starting dose: 200 mg once daily
- Titration: Increase by 200 mg weekly
- Maximum dose: 600 mg once daily
- In long-term studies, 73% of adults used doses ≥400 mg/day, with 36% using the maximum dose of 600 mg/day 3
Special Populations
Patients with Renal Impairment
- Severe renal impairment (eGFR <30 mL/min/1.73m²):
- Starting dose: 100 mg once daily
- Titration: Increase by 50-100 mg weekly
- Maximum dose: 200 mg once daily
- Mild to moderate renal impairment: No dosage adjustment needed 1
Administration Considerations
- Can be taken with or without food
- Capsules should be swallowed whole or contents can be sprinkled over pudding or applesauce
- Do not cut, crush, or chew the capsules
- If sprinkled on food, consume within 15 minutes (pudding) or 2 hours (applesauce) 1
Clinical Monitoring
- Assess heart rate and blood pressure prior to starting treatment, following dose increases, and periodically during therapy
- Screen for personal or family history of suicide, bipolar disorder, and depression before initiating treatment
- Monitor for emergence of suicidal thoughts and behaviors, especially during dose adjustments
- Periodically reevaluate the need for continued treatment 1
Efficacy and Long-Term Use
Long-term studies show that Qelbree is generally well-tolerated and effective for extended periods. In pediatric studies with exposure up to 1896 days (approximately 5.2 years), no new safety concerns emerged with continued use 2. The medication demonstrated sustained improvement in ADHD symptoms throughout the treatment period.
Common Side Effects
The most common adverse effects (≥5% incidence) include:
- Somnolence (9.5%)
- Headache (8.9%)
- Decreased appetite (6.0%)
- Fatigue (5.7%)
- In adults: insomnia (13.8%) and nausea (13.8%) 2, 3
Important Warnings
Qelbree carries a boxed warning for suicidal thoughts and behaviors. In clinical trials, higher rates of suicidal ideation were reported in patients treated with Qelbree (0.9% in pediatric patients and 1.6% in adults) compared to placebo (0.4% in pediatric patients and 0% in adults) 1.
Qelbree is contraindicated in patients:
- Receiving monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing an MAOI
- Receiving sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range 1
Clinical Advantages
Qelbree is a non-stimulant option for ADHD treatment with a relatively faster onset of action (1-2 weeks) compared to atomoxetine (approximately 4 weeks), though direct comparison studies have not been conducted 4.