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FDA-ApprovedExtended-release capsule

Qelbree

viloxazine ER · Supernus Pharmaceuticals

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Key Facts

Form

Extended-release capsule

Frequency

Once daily (morning)

Available Doses

100mg150mg200mg (pediatric max)400mg600mg (adult max)

FDA Approval Date

April 2, 2021

Mechanism

Serotonin-norepinephrine modulating agent (non-stimulant)

Manufacturer

Supernus Pharmaceuticals

Cost

Self-Pay

$300–$450/mo (brand); ~$100–$200/mo (generic)

With Savings Card

Supernus patient savings program available

Medicare

Coverage varies; often requires prior authorization and step therapy

List Price

$480/mo

Generic viloxazine ER available; still more expensive than generic atomoxetine

Side Effects

Side EffectRateSource
Somnolence/fatigue16%FDA label (pediatric)
Nausea11%FDA label (adults)
Decreased appetite9%FDA label
Headache8%FDA label
Insomnia7%FDA label
Irritability5%FDA label (pediatric)
Dizziness3%FDA label

Source: Qelbree FDA Prescribing Information and Phase 3 trials (NCT04155807, NCT04155820)

Weight Loss Results

Phase 3 Pediatric ADHD Trial (P301)

ADHD-RS-5 improvement: −17.0 points vs −11.8 placebo

6 weeks · Treatment regimen (ITT)

6 weeks

Randomized, double-blind, placebo-controlled trial in 477 children aged 6–11. Significant improvement by week 1.

Phase 3 Adult ADHD Trial

ADHD-RS-5 improvement: −14.8 points vs −9.5 placebo

6 weeks · Treatment regimen (ITT)

6 weeks

Double-blind, placebo-controlled trial in 373 adults aged 18–65. 200mg, 400mg, and 600mg doses all outperformed placebo.

How It Works

Qelbree modulates multiple neurotransmitter systems simultaneously: it increases norepinephrine by blocking reuptake, and modulates serotonin through receptor interactions (5-HT2B, 5-HT2C, 5-HT7). This multi-modal action enhances prefrontal cortex function for improved attention and executive control. Unlike atomoxetine, viloxazine often shows clinical improvement within 1–2 weeks rather than 4–6 weeks.

Mechanism: Viloxazine has a multi-modal mechanism: it inhibits the norepinephrine transporter, acts as a 5-HT2B agonist, 5-HT2C antagonist, and 5-HT7 antagonist. This broader pharmacological profile may explain its faster onset compared to selective NRIs like atomoxetine, and may provide additional benefit for patients with comorbid anxiety or mood symptoms.

Who It's For

Indication

ADHD in patients aged 6 and older (children, adolescents, and adults)

Patients with ADHD who need a non-stimulant with faster onset than Strattera. Particularly suitable for patients with comorbid anxiety (serotonin modulation may help), those who experienced sexual side effects on Strattera, or patients who need a non-controlled alternative to stimulants.

Food & Water Restrictions

✅ No Restrictions

This medication can be taken at any time of day, with or without food and water.

Comparisons

Comparison

Strattera vs Qelbree

Read comparison

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Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Clinical trial data referenced comes from published studies and FDA prescribing information. Side effect rates are from specific clinical trials and may not reflect real-world experience. Always consult your healthcare provider before starting, stopping, or switching any medication.