Skip to main content

Qelbree

(viloxazine)

Full Prescribing Information DailyMed Drug Information

Forms/Strengths

  •  Capsules: 100 mg, 150 mg, 200 mg

Dosing

  • Age: ≥ 6 y/o
  • Duration: ~ 24 hours
  • Considerations: Bubblegum-flavored; may be taken with or without food. Shake bottle before administering. Store at room temperature.
  • Initial Dose:
    • 6-11 y/o: 100 mg once daily
    • 12+ y/o: 200 mg once daily
  • Titration:
    • 6-11 y/o: 100 mg weekly
    • 12+ y/o: 200 mg weekly
  • Max Dose:
    • 6-17 y/o: 400 mg daily
    • 17+ y/o: 600 mg daily

Quick Facts

  • Non-stimulant; modulates norepinephrine (and possibly serotonin) to improve ADHD symptoms
  • Enhances focus, attention, and impulse control
  • Extended-release capsule for once-daily dosing
  • Unique alternative for patients intolerant of stimulants
  • Common side effects: decreased appetite, somnolence, fatigue, gastrointestinal discomfort, irritability

Indications

  •  ADHD (ICD-10: F90.0)

Off-Label Uses

  •  N/A

How to Take

  • Take once daily at the same time each day.
  • Can be taken with or without food.
  • Swallow the capsule whole; do not crush, chew, or open.
  • If a dose is missed, take it as soon as possible unless it is close to the next dose—do not double up.
  • Do not abruptly stop taking; consult a healthcare provider before discontinuation.

Side Effects

  • Common: Somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, irritability
  • Serious: Suicidal thoughts and behaviors, blood pressure and heart rate increases, activation of mania or hypomania

Monitoring / Labs

  • Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
  • Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
  • Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
  • Abuse Potential: Monitor for misuse or diversion.

Education

  • When to Call the Doctor:

    • Severe mood changes, aggression, or suicidal thoughts.
    • Symptoms of serotonin syndrome (e.g., rapid heart rate, hallucinations, severe agitation, muscle rigidity, fever).
    • Unusual bruising or bleeding.
    • Signs of liver dysfunction (e.g., yellowing of the skin/eyes, dark urine, persistent nausea).
    • Excessive drowsiness, fainting, or difficulty waking.
  • Safety Tips:

    • Monitor blood pressure and heart rate, as Qelbree may cause changes in vital signs.
    • Use caution in patients with history of depression, bipolar disorder, or suicidal thoughts.
    • Avoid alcohol and sedatives, as they may increase drowsiness.
    • Be cautious when driving or operating heavy machinery until the effects of the medication are known.
    • Tapering may be needed if discontinuing after long-term use.
  • Parent Tips for Pediatric Patients:

    • Monitor for behavioral changes, increased agitation, or suicidal thoughts, particularly in the first few weeks.
    • May cause drowsiness or fatigue—observe how the child responds to the medication.
    • Encourage hydration and balanced meals to minimize side effects.
    • If taken for ADHD, track progress with teachers and caregivers to assess effectiveness.

Additional Information

  • Contraindications:

    • Hypersensitivity to viloxazine or formulation components.
    • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
  • Pregnancy:

    • Category Not Assigned; safety in pregnancy has not been fully established.
    • Use only if the benefits outweigh the potential risks.
  • Lactation:

    • Unknown if excreted in breast milk; use with caution.
  • Drug Interactions:

    • CYP1A2 and CYP2D6 inhibitors (e.g., fluvoxamine, paroxetine) may increase viloxazine levels.
    • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs, St. John’s Wort) increase serotonin syndrome risk.
    • CYP3A4 inducers (e.g., rifampin, carbamazepine) may reduce efficacy.
    • May increase the effects of blood pressure medications, leading to hypotension.