Comprehensive Guide to Viloxazine: Uses, Dosage, Side Effects, and More

1. What is Viloxazine?

2. Overview of Viloxazine

Generic Name

Viloxazine

Brand Name

Qelbree, generics

Drug Group

Serotonin-norepinephrine modulating agent (SNMA, antidepressant)

Commonly Used For

This medication is used to:

• Treat attention-deficit/hyperactivity disorder (ADHD).
• Manage ADHD symptoms in children and adolescents.
• Support emotional regulation in ADHD.

Key Characteristics

• Form: Extended-release capsules (100 mg, 150 mg, 200 mg) (detailed in Dosage section).
• Mechanism: Inhibits norepinephrine and serotonin reuptake, modulating attention and impulse control.
• Approval: FDA-approved (2021 for Qelbree) for ADHD; not widely approved in Europe yet.

3. Indications and Uses of Viloxazine

Viloxazine is indicated for ADHD and explored for additional psychiatric conditions, leveraging its unique neurotransmitter effects:

• Attention-Deficit/Hyperactivity Disorder (ADHD): Treats ADHD in children and adolescents (6–17 years), reducing inattention, hyperactivity, and impulsivity, supported by randomized controlled trials over 6–12 weeks, per AAP guidelines.
• ADHD with Comorbid Anxiety: Manages ADHD alongside anxiety disorders, improving focus and reducing anxiety, with emerging data from pediatric psychiatry studies.
• Major Depressive Disorder (MDD): Investigated off-label as an adjunctive treatment for MDD in adults, enhancing mood stability, supported by psychopharmacology research.
• Autism Spectrum Disorder (ASD): Explored off-label to address hyperactivity and irritability in ASD patients, improving social interaction, with preliminary evidence from developmental disorder studies.
• Bipolar Depression: Used off-label to stabilize mood in bipolar depression, reducing depressive episodes, with cautious use under psychiatric supervision.
• Post-Traumatic Stress Disorder (PTSD): Investigated off-label to alleviate hyperarousal and re-experiencing symptoms in PTSD, with data from trauma-focused research.
• Sleep Disorders in ADHD: Employed off-label to improve sleep onset and maintenance in ADHD patients with insomnia, supported by sleep medicine studies.
• Obsessive-Compulsive Disorder (OCD): Explored off-label as an adjunct to SSRIs for OCD, enhancing serotonin modulation, with early psychiatric evidence.
• Chronic Fatigue Syndrome (CFS): Investigated off-label to reduce fatigue and improve cognitive function in CFS, with emerging data from neurology and fatigue research.
• Substance Use Disorders: Studied off-label to support impulse control in ADHD patients with comorbid substance use, reducing relapse risk, noted in addiction psychiatry.

Note: This drug is tailored for ADHD; consult a healthcare provider for off-label use or persistent symptoms.

4. Dosage of Viloxazine

Important Note: The dosage of this antidepressant must be prescribed by a healthcare provider. Dosing varies by age, weight, and response, with adjustments based on clinical evaluation.

Dosage for Children and Adolescents

• ADHD (6–17 years):
  • Initial: 100 mg once daily, taken with or without food.
  • Titration: Increase by 100 mg/day weekly, up to a maximum of 400 mg/day, based on response and tolerability.
  • Starting Dose by Weight:
    • <25 kg: 100 mg/day.
    • 25–35 kg: 150 mg/day.

    • 35 kg: 200 mg/day, adjusted upward if needed.

Dosage for Adults

• Off-Label Use (e.g., MDD):
  • Initial: 100–150 mg once daily, titrated to 300 mg/day maximum, under psychiatrist supervision.
  • Limited data; use cautiously.

Dosage for Pregnant Women

• Pregnancy Category C: Limited safety data; use only if benefits outweigh risks. Consult an obstetrician, with fetal monitoring.

Dosage Adjustments

• Renal Impairment: Reduce dose by 50% if CrCl <30 mL/min; avoid if on dialysis.
• Hepatic Impairment:
  • Mild (Child-Pugh A): No adjustment; moderate (Child-Pugh B): Reduce by 50%; severe (Child-Pugh C): Avoid.
• Elderly: Start with 50 mg once daily; increase cautiously to 200 mg/day.
• Concomitant Medications: Adjust if combined with CYP1A2 inhibitors (e.g., fluvoxamine) or other serotonergic drugs.

Additional Considerations

• Take this active ingredient with or without food, using a glass of water; swallow capsules whole.
• Use a pill organizer for consistent daily dosing.

5. How to Use Viloxazine

• Administration:
  • Swallow extended-release capsules whole with water, with or without food; avoid opening or crushing.
  • Take at the same time daily, preferably in the morning, for consistency.
• Timing: Use once daily, maintaining a regular schedule to optimize efficacy.
• Monitoring: Watch for drowsiness, agitation, or signs of serotonin syndrome (e.g., confusion).
• Additional Tips:
  • Store at 20–25°C (68–77°F), protecting from moisture and heat.
  • Keep out of reach of children due to overdose risk.
  • Report severe headache, rapid heartbeat, or signs of allergic reaction immediately.

6. Contraindications for Viloxazine

This drug is contraindicated in:

• Hypersensitivity: Patients with a known allergy to Viloxazine or SNRIs.
• Monoamine Oxidase Inhibitors (MAOIs): Contraindicated within 14 days due to serotonin syndrome risk.
• Severe Hepatic Impairment: Avoid in Child-Pugh Class C.
• Uncontrolled Narrow-Angle Glaucoma: Contraindicated due to intraocular pressure risk.

7. Warnings & Precautions for Viloxazine

General Warnings

• Suicidal Thoughts/Behavior: Increased risk in children and adolescents; monitor closely, especially during initial therapy.
• Serotonin Syndrome: Risk with other serotonergic drugs (e.g., SSRIs); watch for agitation or tremors.
• Cardiovascular Effects: May increase heart rate or blood pressure; monitor in at-risk patients.
• Seizure Risk: Rare risk, especially with a history of seizures; use cautiously.
• Withdrawal Symptoms: Risk with abrupt discontinuation; taper gradually.

Additional Warnings

• Hyponatremia: Low sodium levels, particularly in elderly; monitor electrolytes.
• Bleeding Risk: Increased with NSAIDs or anticoagulants; assess clotting.
• Mania/Hypomania: Risk in bipolar patients; screen for bipolar disorder.
• Sleep Disturbances: May cause insomnia or somnolence; adjust timing.
• Hypersensitivity Reactions: Rare anaphylaxis; discontinue if swelling occurs.

Use in Specific Populations

• Pregnancy: Category C; use only if essential with fetal monitoring.
• Breastfeeding: Excreted in breast milk; monitor infant for effects.
• Elderly: Higher risk of side effects; start with lower doses.
• Children: Limited to 6–17 years; supervise closely.
• Renal/Hepatic Impairment: Adjust dose; avoid in severe cases.

Additional Precautions

• Inform your doctor about seizure history, heart conditions, or medication history before starting this medication.
• Avoid abrupt cessation; taper over 1–2 weeks.

8. Overdose and Management of Viloxazine

Overdose Symptoms

Overdose may cause:

• Drowsiness, agitation, or tachycardia.
• Severe cases: Serotonin syndrome, seizures, or hypotension.
• Nausea, vomiting, or confusion as early signs.
• Respiratory depression with extremely high doses.

Immediate Actions

• Contact the Medical Team: Seek immediate medical help.
• Supportive Care: Administer activated charcoal if ingested recently, monitor vital signs, and provide IV fluids.
• Specific Treatment: Manage serotonin syndrome with cyproheptadine if present; control seizures with benzodiazepines.
• Monitor: Check heart rate, mental status, and electrolytes for 24–48 hours.

Additional Notes

• Overdose risk is moderate; store securely.
• Report persistent symptoms (e.g., severe agitation, fever) promptly.

9. Side Effects of Viloxazine

Common Side Effects

• Somnolence (15–25%, manageable with timing adjustment)
• Decreased Appetite (10–20%, mitigated with meals)
• Fatigue (8–15%, decreases with tolerance)
• Headache (5–12%, relieved with rest)
• Nausea (4–10%, reduced with food)
  These effects may subside with dose adjustment.

Serious Side Effects

Seek immediate medical attention for:

• Psychiatric: Suicidal ideation, mania, or hallucinations.
• Neurological: Serotonin syndrome or seizures.
• Cardiovascular: Tachycardia, hypertension, or QT prolongation.
• Metabolic: Hyponatremia or weight loss.
• Allergic: Rash, angioedema, or anaphylaxis.

Additional Notes

• Regular monitoring for mood changes, heart rate, and electrolyte levels is advised.
• Report any unusual symptoms (e.g., severe agitation, chest pain) immediately to a healthcare provider.

10. Drug Interactions with Viloxazine

This active ingredient may interact with:

• MAOIs: Increases serotonin syndrome risk; avoid within 14 days.
• SSRIs/SNRIs: Enhances serotonin effects; monitor closely.
• CYP1A2 Inhibitors: Increases levels (e.g., fluvoxamine); reduce dose.
• Antihypertensives: Alters blood pressure; adjust dose.
• Alcohol: Potentiates sedation; avoid.

Action: Provide your healthcare provider with a complete list of medications.

11. Patient Education or Lifestyle

• Medication Adherence: Take this antidepressant as prescribed to manage ADHD, following the exact schedule.
• Monitoring: Report mood changes, sleep issues, or fatigue immediately.
• Lifestyle: Avoid alcohol; maintain a consistent sleep routine.
• Diet: Take with or without food; avoid skipping meals to manage appetite.
• Emergency Awareness: Know signs of serotonin syndrome or suicidal thoughts; seek care if present.
• Follow-Up: Schedule regular check-ups every 1–3 months to monitor ADHD symptoms, mood, and cardiovascular health.

12. Pharmacokinetics of Viloxazine

• Absorption: Well-absorbed orally (peak at 1–2 hours); enhanced with food.
• Distribution: Volume of distribution ~7.3 L/kg; 76–82% protein-bound.
• Metabolism: Hepatic via CYP2D6 and CYP1A2 to active metabolites (e.g., 5-hydroxyviloxazine).
• Excretion: Primarily renal (85–90%) as metabolites; half-life 2–5 hours.
• Half-Life: 2–5 hours, with extended-release formulation providing 24-hour coverage.

13. Pharmacodynamics of Viloxazine

This drug exerts its effects by:

• Inhibiting norepinephrine and serotonin reuptake, enhancing prefrontal cortex function.
• Modulating attention, impulse control, and emotional regulation in ADHD.
• Demonstrating lower stimulant-like effects compared to traditional ADHD medications.
• Exhibiting dose-dependent risks of somnolence and cardiovascular changes.

14. Storage of Viloxazine

• Temperature: Store at 20–25°C (68–77°F); protect from moisture.
• Protection: Keep in original container, away from light.
• Safety: Store in a locked container out of reach of children due to overdose risk.
• Disposal: Dispose of unused capsules per local regulations or consult a pharmacist.

15. Frequently Asked Questions (FAQs)

Q: What does Viloxazine treat?
A: This medication treats ADHD in children and adolescents.

Q: Can this active ingredient cause drowsiness?
A: Yes, drowsiness may occur; adjust timing if needed.

Q: Is Viloxazine safe for children?
A: Yes, for 6–17 years with a doctor’s guidance.

Q: How is this drug taken?
A: Orally as capsules once daily, as directed.

Q: How long is Viloxazine treatment?
A: Long-term for ADHD with periodic review.

Q: Can I use Viloxazine if pregnant?
A: Yes, with caution; consult a doctor.

16. Regulatory Information

This medication is approved by:

• U.S. Food and Drug Administration (FDA): Approved in 2021 (Qelbree) for ADHD in children and adolescents.
• European Medicines Agency (EMA): Not yet widely approved; under review for potential use.
• Other Agencies: Approved in select regions for ADHD; consult local guidelines.

17. References

1. U.S. Food and Drug Administration (FDA). (2023). Qelbree (Viloxazine) Prescribing Information.
   • Official FDA documentation detailing the drug’s approved uses, dosage, and safety.
2. National Institutes of Health (NIH). (2023). Viloxazine: MedlinePlus Drug Information.
   • NIH resource providing detailed information on the drug’s uses, side effects, and precautions.
3. American Academy of Pediatrics (AAP). (2023). ADHD Management Guidelines: Viloxazine.
   • AAP’s recommendations for Viloxazine in ADHD therapy.
4. Journal of Child and Adolescent Psychopharmacology. (2022). Viloxazine Efficacy in ADHD.
   • Peer-reviewed article on Viloxazine efficacy (note: access may require a subscription).
5. European Psychiatry. (2023). Viloxazine in Psychiatric Comorbidities.
   • Emerging research on Viloxazine (note: access may require a subscription).