What are the indications, side effects, and patient education requirements for Qelbree (viloxazine)?

Qelbree (Viloxazine Extended-Release) Overview

Indications

Qelbree is FDA-approved for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. 1

• Viloxazine functions as a selective norepinephrine reuptake inhibitor with serotonin-norepinephrine modulating properties, representing a nonstimulant treatment option 2
• Clinical trials have demonstrated significant efficacy in reducing ADHD symptoms in both pediatric (ages 6-17) and adult populations 3, 4
• The medication shows particular benefit for inattention, hyperactivity/impulsivity, and executive function impairments 4

Side Effects

Most Common Adverse Reactions

In pediatric patients (≥5% incidence and at least twice placebo rate): somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability. 1

In adult patients (≥5% incidence and at least twice placebo rate): insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth, and constipation. 1

Critical Safety Warnings

• Boxed Warning for Suicidal Thoughts and Behaviors: Higher rates of suicidal ideation were reported in clinical trials compared to placebo; close monitoring is mandatory for clinical worsening and emergence of suicidal thoughts 1
• Blood pressure and heart rate increases: Assess cardiovascular parameters prior to initiation, after dose increases, and periodically during treatment 1
• Activation of mania or hypomania: Screen patients for personal or family history of bipolar disorder before starting treatment 1
• Somnolence and fatigue: Warn patients about potential impairment when driving or operating machinery 1

Long-Term Safety Profile

• In the largest long-term pediatric trial (N=1100, median exposure 260 days), most adverse events were mild to moderate in severity 3
• Discontinuation due to adverse events occurred in 8.2% of pediatric participants and 9.0% of adult participants 3, 4
• No new safety concerns emerged with extended treatment up to 72 months 3

Patient Education

Dosing and Administration

Administer Qelbree once daily in the morning for optimal ADHD symptom control throughout the day. 5

• Therapeutic effects may not be observed until 2-4 weeks after initiation, though some studies show benefits as early as week 2 5, 4
• Capsules can be swallowed whole OR opened and sprinkled onto applesauce or pudding—consume entire contents without chewing within 15 minutes (pudding) or 2 hours (applesauce) 1
• Do not cut, crush, or chew capsules 1
• Can be taken with or without food 1

Dosing Schedules by Age

Pediatric patients 6-11 years:

• Start: 100 mg once daily
• Titrate: Increase by 100 mg weekly as needed
• Maximum: 400 mg once daily 1

Pediatric patients 12-17 years:

• Start: 200 mg once daily
• Titrate: After 1 week, may increase by 200 mg
• Maximum: 400 mg once daily 1

Adults:

• Start: 200 mg once daily
• Titrate: Increase by 200 mg weekly as needed
• Maximum: 600 mg once daily 1

Critical Monitoring Requirements

Patients and caregivers must immediately report any emergence of suicidal thoughts, unusual mood changes, agitation, or behavioral changes. 1

• Monitor heart rate and blood pressure at baseline, after dose increases, and regularly during treatment 1
• Watch for signs of mania or hypomania, particularly in patients with family history of bipolar disorder 1
• Be aware that somnolence and fatigue may impair ability to perform tasks requiring alertness 1

Special Population Warnings

Pregnancy: Discontinue Qelbree when pregnancy is recognized due to limited safety data and potential maternal harm 5, 1

Severe renal impairment (eGFR <30 mL/min/1.73m²):

• Start: 100 mg once daily
• Titrate: Increase by 50-100 mg weekly
• Maximum: 200 mg once daily 1

Drug Interactions

Contraindicated combinations:

• MAOIs (within 14 days of discontinuation) 1
• Sensitive CYP1A2 substrates or those with narrow therapeutic range 1

Not recommended:

• Moderate sensitive CYP1A2 substrates (dose reduction may be warranted if coadministration necessary) 1

Expected Timeline and Outcomes

• Initial symptom improvement may occur within 1-2 weeks, faster than atomoxetine (which typically requires 4 weeks) 6
• Full therapeutic benefit typically observed by 2-4 weeks 5
• Long-term data shows sustained efficacy with continued improvement over time in pediatric populations 3
• Periodically reevaluate the need for continued treatment and adjust dosage as needed 1