Viloxazine is a norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. It is available as extended-release capsules for oral use. MedsAcross supplies Viloxazine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Qelbree is indicated for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. Qelbree is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older
Source: US FDA prescribing information
The mechanism of action of viloxazine in the treatment of ADHD is unclear, however, it is thought to be through inhibiting the reuptake of norepinephrine.
Source: US FDA prescribing information
Pediatric patients 6 to 11 years of age: Recommended starting dosage is 100 mg once daily. May titrate in increments of 100 mg weekly to the maximum recommended dosage of 400 mg once daily. Pediatric patients 12 to 17 years of age: Recommended starting dosage is 200 mg once daily. May titrate after 1 week, by an increment of 200mg, to the maximum recommended dosage of 400 mg once daily. Adult patients: Recommended starting dosage is 200 mg once daily. May titrate in increments of 200 mg weekly, to maximum recommended dosage of 600 mg once daily. Capsules may be swallowed whole or opened and the entire contents sprinkled onto applesauce or pudding. Severe Renal Impairment: Initial dosage is 100 mg once daily. Titrate in weekly increments of 50 mg to 100 mg to a maximum recommended dosage of 200 mg once daily
Source: US FDA prescribing information
Qelbree is contraindicated in patients: receiving concomitant treatment with monoamine oxidase inhibitors (MAOI), or within 14 days following discontinuing an MAOI, because of an increased risk of hypertensive crisis. receiving concomitant administration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range. Concomitant administration of monoamine oxidase inhibitors (MAOI), or dosing within 14 days after discontinuing an MAOI. Concomitant administration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range
Source: US FDA prescribing information
Boxed warning (suicidal thoughts and behaviors): In clinical studies, higher rates of suicidal thoughts and behavior were reported in patients with ADHD treated with Qelbree than in patients treated with placebo. Closely monitor all Qelbree-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. Blood Pressure and Heart Rate Increases: Assess heart rate and blood pressure prior to initiating treatment, following increases in dosage, and periodically while on therapy. Activation of Mania or Hypomania: Screen patients for bipolar disorder. Somnolence and Fatigue: Advise patients to use caution when driving or operating hazardous machinery due to potential somnolence (including sedation and lethargy) and fatigue
Source: US FDA prescribing information
The following serious adverse reactions are described in other sections of the labeling: Suicidal Thoughts and Behaviors Blood Pressure and Heart Rate Increases Activation of Mania or Hypomania Somnolence and Fatigue Most commonly observed adverse reactions (≥5% and at least twice the rate of placebo) were: Pediatric patients 6 to 17 years of age: somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability. Adult patients: insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth and constipation
Source: US FDA prescribing information
Moderate sensitive CYP1A2 substrates: Not recommended for coadministration with Qelbree. Dose reduction may be warranted Drugs Having Clinically Important Interactions with Qelbree Table 3: Clinically Important Drug Interactions with Qelbree Monoamine Oxidase Inhibitors (MAOI) Clinical Impact Concomitant use of Qelbree with an MAOI may lead to a potentially life-threatening hypertensive crisis. Intervention Concomitant use of Qelbree with an MAOI or within 2 weeks after discontinuing an MAOI is contraindicated. Sensitive CYP1A2 Substrates or CYP1A2 Substrates with a Narrow Therapeutic Range Clinical Impact Viloxazine is a strong CYP1A2 inhibitor. Concomitant use of viloxazine significantly increases the total exposure, but not peak exposure, of sensitive CYP1A2 substrates, which may increase the risk of adverse reactions associated with these CYP1A2 substrates.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
3 presentations of Viloxazine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Qelbree 100 mg extended-release capsuleOral | Supernus Pharmaceuticals | US FDA | Available on request |
| Qelbree 150 mg extended-release capsuleOral | Supernus Pharmaceuticals | US FDA | Available on request |
| Qelbree 200 mg extended-release capsuleOral | Supernus Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 2 April 2021 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Viloxazine in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 3 presentations of Viloxazine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Viloxazine, including Qelbree.
Yes. The US FDA first approved Viloxazine on 2 April 2021, according to Drugs@FDA.
No listed presentation of Viloxazine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Viloxazine is classified under ATC code N06AX09 (Viloxazine).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.