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viloxazine

Adjunctive therapy

Brand: Qelbree

Published 2026-02-16 · Last reviewed 2026-02-23 · 4 references

Content sourced from FDA labeling (DailyMed) and peer-reviewed literature.

Print sheet Review evidence

At a glance

Class: Adjunctive therapy·Typical dose: Pediatric ages 6–11: start 100 mg once daily; titrate by 100 mg weekly to a maximum of 400 mg once daily (label).·Half-life: Single-dose mean 7 h·LAI available: No

Class: Adjunctive therapy
Typical dose: Pediatric ages 6–11: start 100 mg once daily; titrate by 100 mg weekly to a maximum of 400 mg once daily (label).
Half-life: Single-dose mean 7 h
LAI available: No

Quick answers

What is viloxazine?: Viloxazine extended-release (brand Qelbree) is a nonstimulant medication indicated for ADHD in patients 6 years and older. It is taken once daily and is not a controlled substance (label/clinical).
What is Qelbree?: Qelbree is a brand name for viloxazine.
What is Qelbree (viloxazine) used for?: Label indications include: Attention-deficit/hyperactivity disorder (ADHD) in patients 6 years and older (label).
What drug class is Qelbree (viloxazine)?: Non-Stimulant ADHD.
What is the mechanism of action of Qelbree (viloxazine)?: Nonstimulant ADHD medication (viloxazine extended-release) that modulates norepinephrine signaling; carries a boxed warning for suicidal thoughts/behaviors and is a strong CYP1A2 inhibitor with clinically important drug interactions.
What strengths does Qelbree (viloxazine) come in?: Extended-release capsules: 100 mg, 150 mg, 200 mg (label).

General information

Viloxazine extended-release (Qelbree) is a nonstimulant medication indicated for ADHD in patients 6 years and older. It is taken once daily and is not a controlled substance (label/clinical).

Qelbree carries a boxed warning for suicidal thoughts and behaviors; monitoring for mood and behavior changes is emphasized during initiation and dose changes (label).

Blood pressure and heart rate can increase; baseline assessment and periodic monitoring are recommended, especially when other activating agents are used (label).

Viloxazine is a strong CYP1A2 inhibitor and can affect exposure of coadministered medications; interaction screening is a central practical step before prescribing (label).

The viloxazine compare view, evidence feed, and print page support shared decision-making about stimulant vs nonstimulant options.

U.S. approvals

Attention-deficit/hyperactivity disorder (patients 6 years and older) (2021)

Formulations & strengths

Extended-release capsules: 100 mg, 150 mg, 200 mg (label).
Capsules may be swallowed whole or opened and sprinkled onto applesauce or pudding (label).

Generic availability

Not available generically (brand-only).

Viloxazine is often considered when a nonstimulant option is preferred (misuse risk, stimulant intolerance, or appetite/weight concerns). The boxed warning for suicidality and the strong CYP1A2 interaction profile are common limiting factors that shape patient selection and monitoring (label/clinical).

View labelExact

Mechanism of action

Refer to the Glossary entry on Neurotransmitters for background on receptor systems involved in serious mental illness.

Viloxazine is a norepinephrine-modulating agent used for ADHD. Its precise mechanism in ADHD is not fully established, but clinical framing emphasizes norepinephrine signaling and downstream executive function effects (label/clinical).

Nonstimulant options are commonly positioned as alternatives when stimulant risks or tolerability issues dominate, with the understanding that response is individualized and requires follow-up (AAP/clinical).

Norepinephrine signaling modulation (clinical framing).

Metabolism & pharmacokinetics

Viloxazine is primarily metabolized by CYP2D6, UGT1A9, and UGT2B15; the major circulating metabolite is 5-hydroxy-viloxazine glucuronide (label).
The mean half-life is ~7 hours, supporting once-daily dosing with an extended-release formulation (label).
Viloxazine is a strong CYP1A2 inhibitor and a weak inhibitor of CYP2D6 and CYP3A4; interaction screening is clinically important, particularly for narrow-therapeutic-range CYP1A2 substrates (label).

Dosing & administration

Pediatric ages 6–11: start 100 mg once daily; titrate by 100 mg weekly to a maximum of 400 mg once daily (label).
Pediatric ages 12–17: start 200 mg once daily; after 1 week may increase by 200 mg to a maximum of 400 mg once daily (label).
Adults: start 200 mg once daily; titrate by 200 mg weekly as needed to a maximum of 600 mg once daily (label).
Severe renal impairment: start 100 mg once daily; titrate in weekly 50–100 mg increments to a maximum of 200 mg once daily (label).
Capsules can be swallowed whole or opened and sprinkled onto applesauce or pudding; the mixture is consumed without chewing within the label-specified time window (label).

Monitoring & labs

Suicidal thoughts and behaviors monitoring during initiation and dose changes (boxed warning; label).
Blood pressure and heart rate assessment at baseline, after dose increases, and periodically (label).
Appetite/weight and sleep monitoring, especially in pediatric patients (clinical).
Drug interaction review focused on CYP1A2 substrates and narrow-therapeutic-range agents (label).

Adverse effects

FDA boxed warnings

Increased risk of suicidal thoughts and behaviors in patients with ADHD; close monitoring for clinical worsening and emergent suicidality is required, especially early in treatment and during dose changes (label).

Common side effects (≥10%)

Somnolence / fatigue: Can affect school/work performance; dose timing and comedications can influence tolerability (clinical).
Decreased appetite: Weight and nutrition monitoring can be clinically useful, especially in pediatrics (clinical).
Nausea: Often improves with time; hydration and food intake review is common (clinical).
Insomnia / irritability: May occur; monitoring is especially important given boxed warning context (label/clinical).
Increased blood pressure / heart rate: Baseline and periodic monitoring is recommended (label).

Other notable effects

Boxed warning monitoring is part of routine care: emergent suicidality, agitation, and significant behavior changes prompt reassessment (label/clinical).
Drug interaction risk is clinically important because viloxazine is a strong CYP1A2 inhibitor (label).

Interactions

Strong CYP1A2 inhibition: coadministration with sensitive CYP1A2 substrates (especially narrow-therapeutic-range agents) is avoided or requires careful adjustment and monitoring (label).
Weak inhibition of CYP2D6 and CYP3A4 can increase exposure of substrates; monitoring and dose adjustments may be needed when combinations are clinically necessary (label/clinical).

Other useful information

ADHD care commonly includes behavioral/educational supports alongside medication; clinicians often document functional targets (school/work performance, impulsivity, sleep) for follow-up (AAP/clinical).
When a nonstimulant is selected to avoid controlled substances, setting expectations about time-to-response and consistent dosing is common (clinical).

References

Related hubs:SMI toolkit·Support resources