Recommended Dosage and Treatment Guidelines for Qelbree (Viloxazine) in ADHD
For adults with ADHD, Qelbree (viloxazine) should be started at 200 mg once daily and titrated in 200 mg weekly increments to a maximum dose of 600 mg daily, while children ages 6-11 should start at 100 mg daily and children 12-17 should start at 200 mg daily, with both pediatric groups having a maximum dose of 400 mg daily. 1
Dosing Guidelines by Age Group
Children 6-11 years:
- Starting dose: 100 mg orally once daily 1
- Titration: May increase by 100 mg weekly increments 1
- Maximum recommended dose: 400 mg once daily 1
- Median modal (most frequently used) dose in long-term studies: 300 mg/day 2
Adolescents 12-17 years:
- Starting dose: 200 mg orally once daily 1
- Titration: May increase by 200 mg after one week 1
- Maximum recommended dose: 400 mg once daily 1
- Median modal dose in long-term studies: 400 mg/day 2
Adults:
- Starting dose: 200 mg orally once daily 1
- Titration: May increase by 200 mg weekly increments 1
- Maximum recommended dose: 600 mg once daily 1
- Most adults (73%) in long-term studies required doses ≥400 mg/day, with 36% using the maximum 600 mg/day dose 3
Administration Guidelines
- Administer orally once daily with or without food 1
- Capsules should be swallowed whole, or can be opened and entire contents sprinkled over pudding or applesauce 1
- If sprinkled, consume the mixture within 15 minutes for pudding or within 2 hours for applesauce, without chewing 1
- Do not cut, crush, or chew the capsules 1
Pre-Treatment Assessment and Monitoring
- Assess heart rate and blood pressure prior to initiating treatment, following dose increases, and periodically during therapy 1
- Screen patients for personal or family history of suicide, bipolar disorder, and depression 1
- Monitor for emergence of suicidal thoughts and behaviors, especially during initial treatment period 1
- In patients with severe renal impairment (eGFR <30 mL/min/1.73m²), start at 100 mg once daily and titrate more slowly to a maximum of 200 mg daily 1
Efficacy and Treatment Response
- Significant improvement in ADHD symptoms can be observed as early as week 2 of treatment 4
- Early response at week 2 is a strong predictor of treatment response at week 6 (75% positive predictive power) 5
- Long-term studies show sustained improvement in ADHD symptoms with continued use 2
- In adults, mean viloxazine ER dose in clinical trials was 504 mg at end of study 4
Safety Considerations and Contraindications
- Contraindicated with concomitant use of MAOIs or within 14 days of discontinuing an MAOI 1
- Contraindicated with concomitant use of sensitive CYP1A2 substrates or CYP1A2 substrates with narrow therapeutic range 1
- Most common adverse events (>10% incidence) include insomnia, nausea, headache, and fatigue 3
- Monitor for increased risk of suicidal thoughts and behaviors (0.9% in pediatric patients and 1.6% in adults vs 0.4% and 0% in placebo groups, respectively) 1
- Periodically reevaluate the long-term use of Qelbree and adjust dosage as needed 1
Special Populations
- Limited data available on efficacy and safety in adults, though recent studies support its use 6
- No published studies on viloxazine use during pregnancy or breastfeeding 6
- Caution is advised if considering use during pregnancy or breastfeeding 6
- Alternative ADHD medications would be preferred during pregnancy or breastfeeding due to limited safety data 6
Clinical Pearls
- Viloxazine is a non-stimulant medication, which may be advantageous in patients with concerns about stimulant abuse potential 5
- As a non-stimulant, viloxazine may be considered when stimulants are ineffective or poorly tolerated 6
- Viloxazine has a relatively rapid onset of action compared to some other non-stimulant options 7
- The mechanism of action involves modulation of both norepinephrine and serotonin systems 5