Viloxazine Hydrochloride
Pronunciation: (vee-LOX-uh-zeen hye-droe-KLOR-ide).
- Generic name
- Viloxazine hydrochloride
- Brand names
- Qelbree
- Drug class
- Mental Health & Psychiatry
Availability and supply rules vary by country
Trade names by country: United States
Australia: · Full directory
What Viloxazine hydrochloride is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how Viloxazine hydrochloride works
Viloxazine hydrochloride is a selective norepinephrine reuptake inhibitor (NRI). It increases norepinephrine levels in the synaptic cleft by inhibiting its reuptake into presynaptic neurons. This action enhances noradrenergic neurotransmission, which is believed to improve attention, focus, and impulse control in patients with ADHD. Viloxazine also has mild serotonergic activity, which may contribute to its clinical effects. (1)
What Viloxazine hydrochloride is used for
Attention-deficit/hyperactivity disorder (ADHD)
Attention-deficit/hyperactivity disorder (ADHD) (2)
Before taking Viloxazine hydrochloride
Do not take / not appropriate for
- hypersensitivity to viloxazine hydrochloride, concurrent use with MAO inhibitors, and severe hepatic impairment. (Contraindication) (2)
Tell your clinician about
(2)How to take Viloxazine hydrochloride
- General Instructions: Take Qelbree exactly as prescribed by your healthcare provider. Do not increase or decrease the dose without consulting your doctor.. Adult Dosing: For adults (18 years and older) with ADHD, the typical starting dose is 200 mg once daily, which may be increased in increments of 200 mg weekly to a maximum of 600 mg once daily based on response and tolerability.. Pediatric Dosing: For children 6–11 years, the starting dose is 100 mg once daily; for adolescents 12–17 years, it is 200 mg once daily. The dose may be increased gradually up to a maximum of 400 mg once daily.. Administration: Take the capsule whole, with or without food. Do not crush, chew, or open the capsule.. When To Seek Review: Do not stop taking Qelbree suddenly without consulting your healthcare provider, as symptoms may return or worsen.. Storage: Store at room temperature (20°C to 25°C / 68°F to 77°F), away from moisture and heat. Keep out of reach of children.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, contact your prescriber or pharmacist for guidance on the missed dose and resume your regular schedule. Do not take two doses at once.
Overdose
In case of overdose, seek emergency medical attention or call your local poison control center immediately. Symptoms may include excessive sleepiness, agitation, vomiting, or seizures. Supportive care and monitoring are recommended. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Nausea
Incidence: Reported in the clinician-authored database; frequency not established
Insomnia
Incidence: Reported in the clinician-authored database; frequency not established
Fatigue
Incidence: Reported in the clinician-authored database; frequency not established
Somnolence
Incidence: Reported in the clinician-authored database; frequency not established
Decreased appetite
Incidence: Reported in the clinician-authored database; frequency not established
Increased blood pressure
Incidence: Reported in the clinician-authored database; frequency not established
Suicidal thoughts and behaviors
Incidence: Reported in the clinician-authored database; frequency not established
Serious warnings
May increase risk of suicidal thoughts or behaviors, especially in children and young adults Can cause liver enzyme elevations—monitor liver function periodically May cause drowsiness or fatigue Not recommended for use with MAO inhibitors Use caution in patients with a history of psychiatric disorders — serious
Symptoms: May increase risk of suicidal thoughts or behaviors, especially in children and young adults Can cause liver enzyme elevations—monitor liver function periodically May cause drowsiness or fatigue Not recommended for use with MAO inhibitors Use caution in patients with a history of psychiatric disorders
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindications include hypersensitivity to viloxazine hydrochloride, concurrent use with MAO inhibitors, and severe hepatic impairment. Use with caution in patients with a history of suicidal ideation, psychiatric disorders, or moderate hepatic or renal impairment. Monitor for emergence of suicidal thoughts or behaviors, especially during initial treatment or dose changes.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Qelbree may interact with other medications that affect the central nervous system, including antidepressants, antiepileptics, and certain antihypertensives. It should not be used with MAO inhibitors due to the risk of serious reactions. Inform your healthcare provider of all medications and supplements you are taking. | (2) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
The FDA label states there are insufficient human data on QELBREE use in pregnancy to establish a drug-associated risk; there is a pregnancy exposure registry that monitors outcomes. Discuss the risks and benefits with the prescriber before use in pregnancy. (2)
Breastfeeding
The FDA label states there is no information on the presence of viloxazine in human milk, its effects on the breastfed infant, or on milk production; a risk to the breastfed infant cannot be ruled out. Discuss breastfeeding with the prescriber. (2)
Children
Frequency: Approved for ADHD in pediatric patients 6 years and older, taken once daily.. Weight Based: Dosing is age-based, not weight-based (6–11 years: start 100 mg once daily; 12–17 years: start 200 mg once daily).. Max Daily Dose: 400 mg once daily for ages 6–17.. Max Single Dose: Given as a single daily dose; do not exceed the prescribed dose.. Age Restrictions: Not approved for children under 6 years; safety and effectiveness established for ages 6–17 in randomized placebo-controlled studies. (2)
Renal_impairment
Renal impairment: no dose adjustment needed for mild-to-moderate impairment (eGFR 30-89); severe impairment (eGFR <30) requires a lower starting dose (100 mg/day) and a lower maximum (200 mg/day). Hepatic impairment: the effect of hepatic impairment on viloxazine's pharmacokinetics is unknown, and the FDA label states QELBREE is not recommended in patients with hepatic impairment. (2)
Hepatic_impairment
Renal impairment: no dose adjustment needed for mild-to-moderate impairment (eGFR 30-89); severe impairment (eGFR <30) requires a lower starting dose (100 mg/day) and a lower maximum (200 mg/day). Hepatic impairment: the effect of hepatic impairment on viloxazine's pharmacokinetics is unknown, and the FDA label states QELBREE is not recommended in patients with hepatic impairment. (2)
Monitoring
(2)Storage
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F), per the FDA label. Keep out of reach of children.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: Attention-deficit/hyperactivity disorder (ADHD)
Dose summary: Initial dose of 200 mg once daily, titrated in increments of 200 mg weekly to a maximum of 600 mg once daily based on clinical response.
Renal context: No dosage adjustment is recommended in patients with mild to moderate renal impairment (eGFR 30-89 mL/min/1.73m^2). For severe renal impairment (eGFR <30 mL/min/1.73m^2), the FDA label recommends starting at 100 mg once daily and titrating in weekly increments of 50-100 mg to a maximum recommended dosage of 200 mg once daily (versus the normal maximum of 400-600 mg depending on age). (1)
Frequently asked questions
How long does it take for Qelbree to start working?
Qelbree may take several weeks to show its full effect. Some improvement in ADHD symptoms may be noticed within the first week, but optimal benefits are usually seen after 2–4 weeks of consistent use.
Is Qelbree a stimulant?
No, Qelbree is a non-stimulant medication for ADHD. It works differently from traditional stimulant medications and is not classified as a controlled substance.
Can adults take Qelbree for ADHD?
Yes, Qelbree is approved for use in adults with ADHD as well as in children and adolescents aged 6 years and older.
What should I do if I miss a dose of Qelbree?
Take the missed dose as soon as you remember. If it is almost time for your next dose, contact your prescriber or pharmacist for guidance on the missed dose and continue your regular schedule. do not take an extra dose doses.
Are there any foods or drinks I should avoid while taking Qelbree?
There are no specific foods to avoid, but you should avoid alcohol as it may increase drowsiness or other side effects.
Can Qelbree be stopped suddenly?
Do not stop Qelbree suddenly without consulting your healthcare provider. Stopping abruptly may cause symptoms to return or worsen.
Does Qelbree interact with other ADHD medications?
Qelbree may interact with other central nervous system medications. Always inform your healthcare provider about all medications you are taking to avoid potential interactions.
What happens if I take too much Qelbree (Viloxazine hydrochloride)?
Taking too much Qelbree (Viloxazine hydrochloride) can lead to overdose symptoms such as seizures, hallucinations, and severe cardiovascular effects. If an overdose is suspected, seek immediate emergency medical attention. Contact poison control or go to the nearest emergency room without delay. Do not attempt to induce vomiting.
Can I drink alcohol while taking Qelbree (Viloxazine hydrochloride)?
It is generally advised to avoid or limit alcohol consumption while taking Qelbree (Viloxazine hydrochloride). Alcohol can intensify central nervous system side effects such as dizziness, drowsiness, and impaired concentration, which are also potential side effects of NRIs. This combination may increase the risk of accidents or other adverse events.
Is Qelbree (Viloxazine hydrochloride) safe during pregnancy?
The safety of Qelbree (Viloxazine hydrochloride) during pregnancy has not been definitively established. It is categorized as 'Consult doctor' for pregnancy. Therefore, if you are pregnant, planning to become pregnant, or breastfeeding, it is crucial to discuss the potential risks and benefits with your healthcare provider before starting or continuing Qelbree.
What is the mechanism of action of Viloxazine hydrochloride?
Viloxazine hydrochloride is a selective norepinephrine reuptake inhibitor (NRI). It increases norepinephrine levels in the synaptic cleft by inhibiting its reuptake into presynaptic neurons. This action enhances noradrenergic neurotransmission, which is believed to improve attention, focus, and impulse control in patients with ADHD. Viloxazine also has mild serotonergic activity, which may contribute to its clinical effects. (1)
What is the generic name of Viloxazine Hydrochloride?
The generic name is Viloxazine hydrochloride. It is sold under brand names including Qelbree.
What class of drug is Viloxazine hydrochloride?
Viloxazine Hydrochloride is classed as: Mental Health & Psychiatry.
References
- Qelbree (viloxazine hydrochloride) prescribing information via MedGuideGlobalMedGuideGlobal · United States · accessed 2026-08-03 · source 1
- QELBREE (viloxazine hydrochloride) FDA-approved prescribing information via DailyMedU.S. National Library of Medicine · United States · accessed 2026-08-07 · source 2
- Viloxazine — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 3
- QELBREE — FDA approval record (Drugs@FDA NDA211964)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
- Viloxazine — RxNorm normalized drug concept (RXCUI 11196)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient Viloxazine hydrochloride names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- QELBREE100 mg, 150 mg, 200 mg · supernus pharmaceuticals, inc