What is the recommended dosage and treatment plan for Quellbree (viloxazine) in attention deficit hyperactivity disorder (ADHD)?

Qelbree (Viloxazine ER) Dosing and Treatment Plan for ADHD

Start Qelbree at age-specific doses—100 mg daily for children 6-11 years, 200 mg daily for adolescents 12-17 years and adults—and titrate weekly by 100-200 mg increments based on response, with maximum doses of 400 mg for pediatric patients and 600 mg for adults. 1

Initial Dosing by Age Group

Pediatric Patients (6-11 years)

• Starting dose: 100 mg orally once daily 1
• Titration: Increase by 100 mg increments at weekly intervals 1
• Maximum dose: 400 mg once daily 1

Adolescents (12-17 years)

• Starting dose: 200 mg orally once daily 1
• Titration: After 1 week, may increase by 200 mg increment 1
• Maximum dose: 400 mg once daily 1

Adults (≥18 years)

• Starting dose: 200 mg orally once daily 1
• Titration: Increase by 200 mg increments weekly 1
• Maximum dose: 600 mg once daily 1

Administration Guidelines

• Timing: Administer once daily in the morning for optimal symptom control throughout the day 2, 3
• Food: May be taken with or without food 1
• Capsule handling: 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

Expected Timeline for Response

Therapeutic effects may not be observed until 2-4 weeks after initiation, though some patients show benefits as early as week 2. 3 In clinical trials, significant improvements in ADHD symptoms were evident by week 2 and continued through week 6 and beyond 4. Early response at week 2 predicts treatment response at week 6 with 75% positive predictive power 5.

Special Population Dosing

Severe Renal Impairment (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-to-moderate renal impairment (eGFR 30-89 mL/min/1.73m²) 1

Pre-Treatment and Monitoring Requirements

Before Starting Treatment

• Cardiovascular assessment: Measure heart rate and blood pressure 1
• Psychiatric screening: Screen for personal or family history of suicide, bipolar disorder, and depression 1

During Treatment

• Reassess vital signs: Following each dose increase and periodically during maintenance 1
• Suicide risk monitoring: Closely monitor for emergence of suicidal thoughts and behaviors, particularly in patients up to age 24 years 1
• Long-term evaluation: Periodically reevaluate the need for continued treatment and adjust dosage as needed 1

Maintenance Dosing Patterns from Clinical Trials

In long-term studies, most adult patients (73%) used doses ≥400 mg/day during maintenance treatment, with 36% using the maximum 600 mg/day dose 6. For pediatric patients, median modal doses were 300 mg/day for children and 400 mg/day for adolescents 7.

Common Adverse Effects to Anticipate

Pediatric Patients (≥5% incidence)

• Somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability 8, 1

Adult Patients (≥5% incidence)

• Insomnia (14.8%), fatigue (11.6%), nausea (10.1%), decreased appetite (10.1%), dry mouth (9.0%), and headache (9.0%) 8, 4

Serious Risks Requiring Monitoring

• Boxed Warning: Suicidal thoughts and behaviors—higher rates reported with Qelbree than placebo in clinical trials (0.9% vs 0.4% in pediatrics; 1.6% vs 0% in adults) 1
• Cardiovascular effects: Increased blood pressure and heart rate 8
• Activation: Risk of mania/hypomania, particularly in patients with bipolar disorder 8
• Somnolence and fatigue: Advise caution with driving or operating machinery 1

Contraindications

Do NOT use Qelbree in patients:

• Receiving MAOIs or within 14 days of discontinuing an MAOI (risk of hypertensive crisis) 1
• Receiving sensitive CYP1A2 substrates or CYP1A2 substrates with narrow therapeutic range 1

Drug Interaction Considerations

• Avoid combination with other serotonergic agents due to serotonin syndrome risk, especially in first 24-48 hours after starting or dose adjustments 8
• Not recommended for coadministration with moderate sensitive CYP1A2 substrates; dose reduction may be warranted 1

Long-Term Safety Profile

Long-term studies (up to 72 months in pediatrics, mean exposure 265 days in adults) demonstrated that viloxazine ER was generally well tolerated with no new safety concerns emerging 6, 7. Discontinuation rates due to adverse events were 8.2% in pediatric long-term studies and 9.0% in adult trials 7, 4.