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Viloxazine

Published: July 26, 2026Updated: July 26, 2026

Viloxazine is a norepinephrine reuptake inhibitor originally developed as an antidepressant that has gained approval for the treatment of attention-deficit/hyperactivity disorder (ADHD). It provides a non-stimulant option for managing ADHD symptoms, making it suitable for patients who may not tolerate or respond well to stimulant medications.

Quick summary

Viloxazine is a norepinephrine reuptake inhibitor used to treat ADHD, originally developed as an antidepressant.

Medically reviewed by WellAlly Editorial TeamLast reviewed July 26, 2026Editorial policy
BOXED WARNING

This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.

Key facts at a glance

ATC
N06AX09
RxNorm
11196
Generic
Viloxazine
Class
atc-n06
Brands
Qelbree
Availability
rx
Lactation
unknown
Routes
oral
Forms
capsule
Regions
US, EU, CN, JP
Monitoring
—

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)tablet
Usual dose
200mg once daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
200mg once daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
100mg once daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Doses significantly exceeding the maximum recommended daily dose of 200 mg may lead to serious toxicity
Chronic overdose: Long-term use exceeding recommended dosing may lead to cumulative toxicity including liver function abnormalities
Immediate actions
supportive care, gastric lavage if within 1-2 hours of ingestion, activated charcoal
Antidote
no specific antidote(supportive care is primary treatment; no specific antidote available)
Poison Control: 1-800-222-1222

Special Populations

11 groups
⚠

pregnancy

first trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

avoid use during pregnancy unless potential benefits justify potential risks to the fetus

Monitor

regular prenatal monitoring

Use with caution and monitor for adverse effects.

⚠

pregnancy

second trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

use only if clearly needed, weigh risks and benefits carefully

Monitor

regular fetal monitoring

Use with caution and monitor for adverse effects.

⚠

pregnancy

third trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

discontinue use near term if possible, discuss with healthcare provider

Monitor

fetal monitoring and assessment for neonatal effects

Use with caution and monitor for adverse effects.

✗

lactation

breastfeeding
unsafe
FDA Category
N
Dose Adjustment

discontinue breastfeeding or discontinue drug

Key Recommendations

vilyoxazine is likely excreted in breast milk, breastfeeding not recommended during treatment

Monitor

monitor infant for adverse effects

Use of this medication in this population requires careful consideration of risks and benefits.

✓

pediatric_age

children 6 to 11 years
safe
FDA Category
N
Dose Adjustment

weight-based dosing, start low

Key Recommendations

approved for ADHD in patients 6-17 years, starting dose 50mg once daily, may increase to 100mg

Monitor

monitor growth, weight, and blood pressure

✓

pediatric_age

adolescents 12 to 17 years
safe
FDA Category
N
Dose Adjustment

standard adult dosing may be used

Key Recommendations

approved for ADHD, starting dose 50mg once daily, may increase to 200mg maximum

Monitor

monitor blood pressure, heart rate, and psychiatric symptoms

⚠

geriatric

elderly 65 years and older
caution
FDA Category
N
Dose Adjustment

start at lowest effective dose

Key Recommendations

use with caution, limited clinical experience in elderly population, monitor for orthostatic hypotension

Monitor

monitor blood pressure, renal function, and for adverse effects

Use with caution and monitor for adverse effects.

⚠

renal_impairment

mild renal impairment
caution
FDA Category
N
Dose Adjustment

no dose adjustment typically required

Key Recommendations

use with caution, monitor renal function periodically

Monitor

periodic renal function monitoring

Use with caution and monitor for adverse effects.

⚠

renal_impairment

severe renal impairment
caution
FDA Category
N
Dose Adjustment

dose reduction recommended

Key Recommendations

reduce dose to minimum effective dose, avoid use in end-stage renal disease

Monitor

close monitoring of renal function and drug levels if available

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

mild to moderate hepatic impairment
caution
FDA Category
N
Dose Adjustment

no specific dose adjustment in mild impairment

Key Recommendations

use with caution, start at lower dose

Monitor

monitor liver function tests

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

severe hepatic impairment
caution
FDA Category
N
Dose Adjustment

reduce dose significantly

Key Recommendations

use with extreme caution, limited data available

Monitor

close monitoring of liver function and clinical response

Use with caution and monitor for adverse effects.

Statistics and clinical data

drug_classFDA
2023

Drug class

Value:Selective norepinephrine reuptake inhibitor (SNRI)

Viloxazine is a non-stimulant ADHD medication classified as an SNRI

approvalFDA
2023

FDA approval year

Value:2021

FDA approved Viloxazine (Qelbree) for ADHD treatment

usageFDA
2023

Primary indication

Value:Attention Deficit Hyperactivity Disorder (ADHD)

Approved for treatment of ADHD in pediatric patients ages 6-17

prescribingFDA
2023

Brand name

Value:Qelbree

Commercial brand name for Viloxazine

Viloxazine is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD). Originally developed as an antidepressant, it has received approval for ADHD management in applicable regions.

The precise mechanism by which viloxazine exerts its therapeutic effect in ADHD is not fully elucidated; however, it is believed to function by inhibiting the reuptake of norepinephrine, thereby increasing norepinephrine availability in the brain.

Viloxazine should be used under medical supervision. Patients should disclose their complete medical history and all current medications to their healthcare provider before initiating treatment. Side effects may include somnolence, fatigue, headache, and decreased appetite. Its non-stimulant classification offers an alternative for patients who cannot tolerate stimulant-based ADHD treatments.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy