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Qelbree

(viloxazine)

Qelbree (viloxazine); not controlled

Full Prescribing Information DailyMed Drug Information

Summary

Qelbree is a selective norepinephrine reuptake inhibitor supplied as an extended-release capsule taken once daily, approved for ADHD in adults and in children from 6 years of age. It is the second non-stimulant of its class to reach the market and is titrated by fixed milligram steps rather than by weight, which makes the dose ladder simpler than atomoxetine's. Its defining prescribing constraint is that it is a strong CYP1A2 inhibitor, so sensitive CYP1A2 substrates are contraindicated outright rather than merely cautioned. Not controlled; brand only, with no generic marketed.

Forms & Strengths

  • Extended-release capsules: 100 mg, 150 mg, 200 mg
  • No oral liquid exists. The label's answer for a child who cannot swallow is to sprinkle the capsule contents

Dosing

  • Age: 6 y/o and older, and adults; not established below 6 y/o
  • Onset: weeks to clinical effect; not a rescue or as-needed medication
  • Duration: continuous with once-daily dosing; steady state in 2 days, no accumulation
  • Release Profile: extended-release beaded capsule, about 88% relative bioavailability against an immediate-release reference, median Tmax 5 hours (range 3 to 9)
  • Initial Dose:
    • 6 to 11 y/o: 100 mg once daily
    • 12 to 17 y/o: 200 mg once daily
    • 18 y/o and over: 200 mg once daily
  • Titration:
    • 6 to 11 y/o: 100 mg every 7 days
    • 12 to 17 y/o: a single 200 mg increment after 1 week
    • 18 y/o and over: 200 mg every 7 days
  • Max Dose:
    • 6 to 11 y/o: 400 mg/day
    • 12 to 17 y/o: 400 mg/day
    • 18 y/o and over: 600 mg/day
  • Considerations: In severe renal impairment (eGFR under 30 mL/min/1.73 m2) start at 100 mg once daily, titrate by 50 to 100 mg weekly, and cap at 200 mg/day at any age. No adjustment for mild or moderate impairment.

Pharmacology

  • Mechanism: Selective norepinephrine reuptake inhibitor; raises synaptic NE and, indirectly, prefrontal dopamine. The label adds 5-HT2C binding with partial agonist activity. [VERIFY: house rule says 5-HT2C antagonism plus 5-HT2B agonism; this label says 5-HT2C partial agonism only]
  • Delivery / Release: Extended-release beaded capsule, about 88% relative bioavailability, median Tmax 5 hours. Food effects are not clinically meaningful, whether taken with a meal or sprinkled.
  • Metabolism: Primarily CYP2D6, UGT1A9 and UGT2B15, to 5-hydroxy-viloxazine glucuronide. Half-life 7.0 hours (SD 4.7), protein binding 76 to 82%. Elimination is renal: 90% recovered in urine within 24 hours, under 1% in feces.
  • Pharmacogenomics: no CYP2D6-based dose adjustment, unlike atomoxetine. Do not extrapolate atomoxetine's poor-metabolizer guidance to this drug.
  • Class Positioning: Same noradrenergic mechanism as atomoxetine (Strattera), but titrated in fixed milligram steps and carrying a strong CYP1A2 inhibition liability atomoxetine lacks.

Indications

  • Attention-Deficit/Hyperactivity Disorder (ICD-10: F90.x): patients 6 y/o and older, and adults

Off-Label Uses

  • None established. No off-label pediatric use meets even the "limited data" descriptor
  • Where the evidence does not support use:
    • Depressive disorders (ICD-10: F32.x, F33.x): insufficient in youth. European antidepressant use decades ago is not evidence for this product at ADHD doses, and the drug can activate mania
    • ADHD in autism spectrum disorder (ICD-10: F84.0 with F90.x): insufficient; no viloxazine-specific grade in this population. (AHRQ 2024)
    • Comorbid tic disorders and anxiety (ICD-10: F95.2, F41.x): insufficient. Unlike atomoxetine, this label carries no non-worsening trials; absence of a reassuring trial is not a reassuring result

Contraindications & Warnings

  • Boxed Warning: SUICIDAL THOUGHTS AND BEHAVIORS
    • Pediatric: 9 of 1,019 (0.9%) reported ideation, behaviour or both, against 2 of 463 (0.4%) on placebo
    • Adults: 3 of 189 (1.6%) against 0 of 183 on placebo; no attempted or completed suicides
    • Monitor closely for clinical worsening, especially in the first months and at every dose change
  • Contraindicated:
    • MAOI use, or within 14 days of stopping one; risk of life-threatening hypertensive crisis
    • Any sensitive CYP1A2 substrate, or any CYP1A2 substrate with a narrow therapeutic range. Viloxazine is a strong CYP1A2 inhibitor; this is absolute, not a caution
  • Use with caution:
    • Pre-existing hypertension or tachycardia; dose-related rise in rate and diastolic pressure
    • Bipolar disorder or risk factors; can induce a manic or mixed episode
    • Any situation requiring alertness; somnolence 16% against 4% on placebo
    • Severe renal impairment (eGFR under 30 mL/min/1.73 m2), where the ceiling falls to 200 mg/day
    • Moderate sensitive CYP1A2 substrates, not recommended; if unavoidable, reduce the substrate dose
  • Screen before starting:
    • Heart rate and blood pressure; an explicit labeled pre-treatment step
    • Psychiatric history including family history of suicide, bipolar disorder and depression
    • Full medication list checked for CYP1A2 substrates, which are contraindicated
    • Renal function where impairment is suspected; height and weight on a growth chart

Drug Interactions

  • MAOIs (phenelzine, tranylcypromine, linezolid, IV methylene blue): hypertensive crisis. Do not co-prescribe; allow 14 days in either direction
  • Sensitive and narrow-therapeutic-range CYP1A2 substrates: strong inhibition raises exposure substantially. Do not co-prescribe
  • Moderate sensitive CYP1A2 substrates: same mechanism, lesser magnitude. Not recommended; if unavoidable, reduce the substrate dose and watch for toxicity
  • CYP2D6 substrates (many antidepressants, antipsychotics, beta-blockers, class 1C antiarrhythmics): weak inhibition raises exposure. Monitor and adjust the substrate dose
  • CYP3A4 substrates: weak inhibition raises exposure. Monitor and adjust the substrate dose

Administration

  • Once daily, at the same time each day, with or without food
  • Swallow whole, or open and sprinkle the entire contents over a teaspoonful or tablespoonful of pudding or applesauce
  • If sprinkled, eat the mixture whole without chewing: within 15 minutes for pudding, 2 hours for applesauce. Never store a prepared mixture
  • Do not cut, crush or chew the capsule or its contents
  • Move the dose to the evening if daytime somnolence limits treatment
  • Missed dose: the label gives no instruction; resume the usual schedule and do not double up
  • For a child who needs a true liquid non-stimulant, atomoxetine is available as a 4 mg/mL oral solution

Side Effects

  • Common (pooled pediatric trials, all doses vs placebo):
    • Somnolence including sedation and lethargy 16 vs 4%, headache 11 vs 7%, decreased appetite 7 vs 0.4%
    • Upper respiratory infection 7 vs 6%, fatigue 6 vs 2%, abdominal pain 5 vs 4%, nausea 5 vs 3%
    • Vomiting 4 vs 2%, insomnia 4 vs 1%, irritability 3 vs 1%. Somnolence, fatigue and insomnia are dose related
  • Serious:
    • Suicidal thoughts and behaviour, the boxed warning; consider stopping if they emerge, or on new insomnia, agitation or akathisia
    • Blood pressure and heart rate rise: at 400 mg/day, 28% to 34% rose at least 20 bpm and 25% of adolescents at least 15 mm Hg diastolic
    • Activation of mania or hypomania; stop and reassess the diagnosis
    • Somnolence and fatigue impairing driving in adolescents; move or reduce the dose
    • Weight: over 6 to 8 weeks, ages 6-11 gained 0.2 vs 1 kg placebo; ages 12-17 lost 0.2 vs a 1.5 kg gain. Weight-for-age z-score -0.2 at 12 months

Monitoring & Labs

  • Cardiovascular: heart rate and blood pressure at baseline, after every increase, then every 3 months; act on a sustained rise of 20 bpm or 15 mm Hg diastolic
  • Suicidality: screen at every visit for 3 months and at every dose change; ask about new insomnia and irritability, named as precursors
  • Growth: height and weight at baseline, every 3 months for a year, then every 6 months; the adolescent weight signal is the larger one
  • Psychiatric: ask about manic and hypomanic symptoms at each titration visit and every 3 months once stable
  • Daytime alertness: ask the school as well as the family, at each titration visit and every 6 months; the commonest reason for stopping
  • Medication reconciliation: recheck the full list at every visit for newly added CYP1A2 substrates, which are contraindicated
  • Renal function: no routine schedule; recheck eGFR when circumstances change

Discontinuation & Taper

  • The label gives no tapering instruction and describes no withdrawal syndrome. [VERIFY: absence of a taper instruction is not a positive statement that abrupt cessation is safe]
  • Discontinue and reassess if suicidal thoughts or behaviours emerge, or if mania or hypomania is activated
  • Discontinue or reduce the dose for a sustained rise in heart rate or diastolic blood pressure
  • Drug holidays are not appropriate. The effect depends on continuous daily exposure over weeks
  • Reevaluate long-term use periodically, adjusting the dose as needed

Pregnancy & Lactation

  • Pregnancy: discontinue Qelbree when pregnancy is recognized unless benefit outweighs maternal risk, on animal findings of maternal harm and malformations. Human data insufficient. Raise before starting in an adolescent who could conceive.
  • Lactation: present in breastmilk; at 600 mg daily the estimated infant dose was 0.085 mg/kg, a relative infant dose about 1%. No data on infant effects or milk production. (LactMed 2025)
  • Exposure Registry: National Pregnancy Registry for Psychiatric Medications, 1-866-961-2388, womensmentalhealth.org/preg

Counseling Points

  • Counsel the family on:

    • Judging the medication over 6 to 8 weeks, not over a day; name the review date at the first visit
    • Daytime sleepiness in about one child in six; moving the dose to the evening is the normal fix
    • Sprinkling onto pudding or applesauce if needed, eaten whole without chewing
    • Telling every prescriber and pharmacist about Qelbree; it raises the level of several other medicines and a few cannot be given at all
    • Giving it every day including weekends and holidays
    • Watching daily in the first month for new agitation, irritability or trouble sleeping

  • Advise them to call for:

    • New or worsening talk of self-harm, or any sudden mood or behaviour change
    • New difficulty falling asleep, or new irritability, in the first weeks
    • A racing or pounding heartbeat, or recurring headaches
    • Sleepiness stopping a child staying awake at school, or an adolescent unsafe to drive
    • A sudden burst of unusually high energy, reduced need for sleep, or racing speech
    • Any new prescription from another clinician, before its first dose

References

  1. DailyMed. Qelbree (viloxazine extended-release capsules) prescribing information. 2025. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aedf408d-0f84-418d-9416-7c39ddb0d29a
  2. LactMed. Viloxazine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2025. https://www.ncbi.nlm.nih.gov/books/NBK588747/
  3. AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK603001/
  4. FDA. National Drug Code Directory, openFDA. Queried by generic name viloxazine. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22viloxazine%22&limit=1000
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