How to titrate Qelbree (Viloxazine) in a 6-year-old boy with Attention Deficit Hyperactivity Disorder (ADHD) who remains hyperactive?

Qelbree (Viloxazine) Titration Protocol for a 6-Year-Old Boy with Persistent Hyperactivity

For a 6-year-old boy with ADHD who remains hyperactive on Qelbree, start with 100 mg once daily and titrate in increments of 100 mg at weekly intervals to a maximum dosage of 400 mg once daily, based on response and tolerability. 1

Initial Dosing and Titration Schedule

• The FDA-approved starting dose for children 6-11 years is 100 mg orally once daily 1
• Increase dosage in increments of 100 mg at weekly intervals 1
• Maximum recommended dosage for this age group is 400 mg once daily 1
• Titration should be based on both clinical response and tolerability 1

Administration Guidelines

• Qelbree can be administered with or without food 1
• The capsule may be swallowed whole or opened and sprinkled over a teaspoonful of applesauce or pudding 1
• If sprinkled, the mixture should be consumed within 2 hours for applesauce or 15 minutes for pudding, without chewing 1
• Do not cut, crush, or chew the capsules 1

Monitoring During Titration

• Assess heart rate and blood pressure prior to initiating treatment, following each dose increase, and periodically during therapy 1
• Monitor for common side effects including somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability 1
• Pay special attention to any emergence of suicidal thoughts or behaviors, as these were reported at higher rates in Qelbree-treated patients than placebo in clinical trials 1

Optimizing Response

• Allow at least one week at each dose level to properly assess response before making further adjustments 1
• Early response to viloxazine treatment (change in ADHD symptoms at week 2) is a good predictor of treatment response at week 6 2
• If the child shows inadequate response at the maximum dose of 400 mg daily, consider alternative treatment options 1

Important Safety Considerations

• Screen for personal or family history of suicide, bipolar disorder, and depression before initiating treatment 1
• Monitor for activation of mania or hypomania during treatment 1
• Be aware that somnolence and fatigue are common side effects that may affect school performance 1
• Viloxazine has a unique mechanism of action as a selective norepinephrine reuptake inhibitor that also modulates serotonergic activity 2

When to Consider Alternative Treatments

• If the child experiences intolerable side effects despite dose adjustments 1
• If symptoms remain inadequately controlled at the maximum recommended dose 1
• Stimulant medications (methylphenidate, amphetamines) remain first-line pharmacologic treatments for ADHD with response rates of approximately 70% 2
• Other non-stimulant options include atomoxetine, extended-release guanfacine, and extended-release clonidine 3

Viloxazine represents a newer non-stimulant option for ADHD treatment with a relatively rapid onset of action and sustained symptom improvement 4. Regular follow-up appointments should be scheduled to assess response and adjust treatment as needed.