- Attention-deficit/hyperactivity disorder (ADHD) in patients 6 years and older
- Non-stimulant ADHD treatment option
- ADHD in patients with substance abuse history
- ADHD with comorbid anxiety or tic disorders
- Alternative when stimulants are not tolerated
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Viloxazine
Generic Name: Viloxazine
Brand Names: Qelbree
Viloxazine is a newer non-stimulant medication for ADHD that works through norepinephrine reuptake inhibition.
PsychiatricNon-Stimulant
Drug Class
Selective Norepinephrine Reuptake Inhibitor (SNRI) – Non-Stimulant ADHD Agent
Pregnancy
Not formally categorized – Limited human data. Animal studies at high doses showed decreased fetal weight. Use only if benefit outweighs risk.
Available Forms
100 mg extended-release oral capsule, 150 mg extended-release oral capsule, 200 mg extended-release oral capsule
What It's Used For
Dosage Quick Reference
These are general dosage guidelines. Your doctor will determine the appropriate dose for your specific situation.
| Condition | Starting Dose | Typical Maintenance Dose |
|---|---|---|
| ADHD (children 6–11 years) | 100 mg once daily in the morning | 100–400 mg once daily (titrate weekly by 100 mg) |
| ADHD (adolescents 12–17 years) | 200 mg once daily in the morning | 200–400 mg once daily (titrate weekly by 200 mg) |
| ADHD (adults, off-label) | 200 mg once daily in the morning | 200–600 mg once daily (clinician-guided titration) |
Side Effects
Common Side Effects:
- Somnolence (sleepiness)
- Decreased appetite
- Nausea and vomiting
- Headache
- Insomnia
- Fatigue
- Irritability
Serious Side Effects (seek immediate medical attention):
- Suicidal thoughts or behavior
- New or worsening depression, anxiety, or agitation
- Severe allergic reactions
- Increased blood pressure or heart rate
- Manic episodes
Drug Interactions
Major Drug & Food Interactions
- MAO inhibitors: Contraindicated within 14 days. Risk of serious hypertensive and serotonergic reactions.
- Sensitive CYP1A2 substrates (theophylline, tizanidine, alosetron): Viloxazine is a strong CYP1A2 inhibitor and can substantially increase levels of these drugs, potentially causing toxicity. Avoid or reduce doses.
- CYP2D6 substrates (atomoxetine, dextromethorphan, certain antidepressants): Viloxazine moderately inhibits CYP2D6 and can raise levels of these medications.
- CYP3A4 substrates (midazolam, certain statins): Viloxazine weakly inhibits CYP3A4; monitor for increased effects.
- Other noradrenergic agents (duloxetine, venlafaxine): Additive norepinephrine effects may increase blood pressure and heart rate.
Additional Information
Viloxazine is a selective norepinephrine reuptake inhibitor (SNRI) approved for treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adults. Originally developed as an antidepressant in Europe, it was reformulated as an extended-release product (Qelbree) specifically for ADHD treatment in the United States.
How Viloxazine Works
Viloxazine primarily inhibits norepinephrine reuptake, increasing norepinephrine availability in the brain. It also has moderate activity at serotonin receptors (5-HT2B agonist and 5-HT2C antagonist) and weakly inhibits serotonin reuptake. This mechanism differs from stimulant medications but still improves attention and reduces impulsivity.
Available Formulations
Viloxazine extended-release capsules (Qelbree) are available in:
- 100 mg
- 150 mg
- 200 mg
Capsules can be swallowed whole or opened and sprinkled on applesauce for patients who have difficulty swallowing.
Medical Uses
Viloxazine is FDA-approved for ADHD in patients aged 6 years and older. It provides a non-stimulant option for patients who cannot tolerate or prefer to avoid stimulant medications. It may be particularly useful for patients with comorbid anxiety, tic disorders, or substance abuse history.
Dosing Information
For children aged 6-11 years, the starting dose is 100 mg once daily, which can be increased weekly to a maximum of 400 mg daily. For adolescents and adults, the starting dose is 200 mg once daily with a maximum of 400 mg daily. The medication should be taken in the morning.
Important Safety Information
Viloxazine carries a boxed warning for suicidal thoughts and behavior in children, adolescents, and young adults. Close monitoring is essential, especially during the first few months of treatment. The medication should not be used with MAO inhibitors due to risk of serious reactions.
Advantages as Non-Stimulant
Unlike stimulant ADHD medications, viloxazine is not a controlled substance and has no abuse potential. It does not cause appetite suppression or sleep problems to the same degree as stimulants. It can be used in patients with contraindications to stimulants or those with substance abuse concerns.
Drug Interactions
Viloxazine is a moderate CYP1A2 inhibitor and can increase levels of medications metabolized by this enzyme. Caution is needed with sensitive CYP1A2 substrates like duloxetine, alosetron, and theophylline. MAO inhibitors are contraindicated. Combining with other serotonergic drugs requires monitoring.
Special Populations
Safety and efficacy have been established in children 6 years and older. The medication should be used during pregnancy only if benefits outweigh risks. It is unknown whether viloxazine passes into breast milk. Dose adjustment may be needed in patients with severe renal impairment.
Clinical Response Timeline
Unlike stimulants that work immediately, viloxazine may take 1-2 weeks to show initial effects and several weeks for full therapeutic benefit. Patients should be counseled about this timeline to set appropriate expectations.
Learn more at MedlinePlus
Frequently Asked Questions
Viloxazine is a non-stimulant that works primarily by inhibiting norepinephrine reuptake, with some serotonergic activity. It is not a controlled substance, so it does not carry the same abuse potential as stimulants like methylphenidate or amphetamines.
Some patients notice improvements within the first week, but full therapeutic effects may take several weeks. Your clinician will monitor progress and adjust the dose as needed.
Yes. The extended-release capsule can be opened and the contents sprinkled on a spoonful of applesauce. Swallow the mixture immediately without chewing. Do not store the mixture for later use.
Decreased appetite and weight loss have been reported in clinical trials. Your doctor should monitor weight regularly, especially in growing children and adolescents.
Like other medications affecting norepinephrine and serotonin, viloxazine carries an FDA boxed warning for suicidal thinking and behavior in children and young adults. Families and caregivers should watch for changes in mood, unusual behavior, or suicidal thoughts, especially in the first few months.
Questions to Ask Your Doctor
Consider discussing these topics at your next appointment:
- ✓Is a non-stimulant the best choice for my ADHD, or should we consider a stimulant as well?
- ✓Are any of my other medications metabolized by CYP1A2 or CYP2D6 enzymes?
- ✓What should I watch for in terms of mood changes or suicidal thoughts?
- ✓How will we track whether viloxazine is improving my attention and focus?
- ✓Should my blood pressure be monitored regularly while taking this medication?
Related Health Conditions
This medication is commonly used to treat or manage the following conditions:
Medical Disclaimer: This information is for educational purposes only and should not be considered medical advice. Always consult with your healthcare provider before starting, stopping, or changing any medication. Your doctor can provide personalized recommendations based on your specific health condition and medical history.
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Questions About This Medication?
Talk to your doctor or pharmacist about whether Viloxazine is right for you.
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