Qelbree (Viloxazine Extended-Release) Dosing and Treatment Plan for ADHD
Qelbree is dosed once daily with age-specific starting doses and titration schedules: children 6-11 years start at 100 mg daily (maximum 400 mg), adolescents 12-17 years start at 200 mg daily (maximum 400 mg), and adults start at 200 mg daily (maximum 600 mg), with weekly dose adjustments based on response and tolerability. 1
Pre-Treatment Assessment Requirements
Before initiating Qelbree, you must complete the following baseline evaluations 1:
- Cardiovascular monitoring: Measure heart rate and blood pressure prior to treatment initiation, after each dose increase, and periodically during maintenance therapy 1
- Psychiatric screening: Screen for personal or family history of suicide, bipolar disorder, and depression given the boxed warning for suicidal ideation and behavior 1
- Renal function: Assess estimated glomerular filtration rate (eGFR) to determine if dose adjustments are needed 1
Dosing by Age Group
Children Ages 6-11 Years
- Starting dose: 100 mg orally once daily 1
- Titration schedule: Increase in 100 mg increments at weekly intervals based on response and tolerability 1
- Maximum dose: 400 mg once daily 1
- Median maintenance dose in clinical trials: 300 mg/day 2
Adolescents Ages 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
- Median maintenance dose in clinical trials: 400 mg/day 2
Adults Ages 18-65 Years
- Starting dose: 200 mg orally once daily 1
- Titration schedule: Increase in 200 mg increments weekly based on response and tolerability 1
- Maximum dose: 600 mg once daily 1
- Mean dose in clinical trials: 504 mg/day at study endpoint 3
- Maintenance dosing: 73% of adults used doses ≥400 mg/day during long-term treatment, with 36% requiring the maximum 600 mg/day dose 4
Administration Instructions
Qelbree can be taken with or without food 1. The capsules should be swallowed whole without cutting, crushing, or chewing 1. For patients unable to swallow capsules whole:
- Open the capsule and sprinkle entire contents over 1 teaspoon or tablespoon of pudding or applesauce 1
- Consume the entire mixture without chewing within 15 minutes for pudding or within 2 hours for applesauce 1
- Do not store the mixture for future use 1
Special Population Dosing
Severe Renal Impairment (eGFR <30 mL/min/1.73m²)
- Starting dose: 100 mg once daily (regardless of age) 1
- Titration: Increase in 50-100 mg increments weekly 1
- Maximum dose: 200 mg once daily 1
- Mild to moderate renal impairment: No dose adjustment required 1
Pregnancy and Breastfeeding
Avoid Qelbree during pregnancy and breastfeeding due to limited safety data; alternative ADHD medications are preferred 5. The American College of Obstetricians and Gynecologists advises caution when considering viloxazine use in these populations 5.
Timeline for Clinical Response
Early response assessment is critical for predicting treatment success 6:
- Week 2: Evaluate for early response; a reduction in ADHD-RS total score at week 2 predicts week 6 response with 75% positive predictive power and 75% sensitivity 6
- Onset of action: Clinical improvement typically occurs within 1-2 weeks, which is faster than atomoxetine's 4-week onset 7
- Week 6: Primary endpoint for assessing full therapeutic response 3
- Long-term: Continued improvement may occur beyond initial response, with sustained efficacy demonstrated over extended treatment periods 2
Critical Safety Monitoring
Boxed Warning: Suicidal Ideation and Behavior
Closely monitor all patients for clinical worsening and emergence of suicidal thoughts and behaviors 1:
- In pediatric trials, 0.9% of patients on Qelbree reported suicidal ideation or behavior versus 0.4% on placebo 1
- In adult trials, 1.6% on Qelbree reported suicidal ideation versus 0% on placebo 1
- Higher rates of insomnia and irritability occurred with Qelbree, which may contribute to psychiatric symptoms 1
Cardiovascular Effects
Monitor for blood pressure and heart rate increases at baseline, after dose adjustments, and periodically during treatment 1.
Activation of Mania/Hypomania
Screen patients for bipolar disorder before initiating treatment 1.
Common Adverse Effects
Pediatric patients (≥5% and twice placebo rate): somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability 1
Adult patients (≥5% and twice placebo rate): insomnia (14.8%), headache, somnolence, fatigue (11.6%), nausea (10.1%), decreased appetite (10.1%), dry mouth (9.0%), and constipation 1, 3
Drug Interactions and Contraindications
Absolute contraindications 1:
- Concomitant use with MAOIs or within 14 days of discontinuing an MAOI (risk of hypertensive crisis) 1
- Concomitant use with sensitive CYP1A2 substrates or those with narrow therapeutic range 1
Not recommended: Co-administration with moderate sensitive CYP1A2 substrates; dose reduction of the CYP1A2 substrate may be warranted 1
Position in ADHD Treatment Algorithm
Viloxazine should be considered as a non-stimulant option when stimulants are ineffective or poorly tolerated 5. The American Academy of Pharmacology and Therapeutics suggests viloxazine as an alternative non-stimulant medication option in these circumstances 5.
While stimulants remain first-line treatment with effect sizes of approximately 1.0, viloxazine (as a selective norepinephrine reuptake inhibitor) has demonstrated efficacy with an effect size comparable to other non-stimulants 8. Atomoxetine has an effect size of approximately 0.7, and extended-release guanfacine and clonidine also have effect sizes of approximately 0.7 8.
Long-Term Treatment Considerations
Periodically reevaluate the long-term use of Qelbree and adjust dosage as needed, as pharmacological treatment of ADHD may be required for extended periods 1. In long-term studies: