viloxazine

Adjunctive therapy

Brands: Qelbree

Last reviewed 2025-12-30

Reviewed by PsychMed Editorial Team.

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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)?
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).

Snapshot

Class: Adjunctive therapy
Common US brands: Qelbree
Therapeutic drug monitoring not routinely recommended.
Last reviewed: 2025-12-30

Label indications

Attention-deficit/hyperactivity disorder (ADHD) in patients 6 years and older (label).

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Clinical Highlights

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

Compared with stimulants, viloxazine is often discussed when misuse risk, appetite/weight concerns, or stimulant intolerance are prominent, though response is individualized and follow-up remains important (AAP/clinical).
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 a weak CYP2D6/CYP3A4 inhibitor), so drug–drug interaction review is a central practical step before prescribing (label).
The compare view, viloxazine evidence feed, and viloxazine print page help compare nonstimulant and stimulant options.

Dosing & Formulations

Extended-release capsules: 100 mg, 150 mg, 200 mg (label). Pediatric ages 6–11: start 100 mg once daily; increase by 100 mg weekly to a maximum of 400 mg once daily, based on response and tolerability (label).

Pediatric ages 12–17: start 200 mg once daily; after 1 week may increase by 200 mg to 400 mg once daily, based on response and tolerability (label).
Adults: start 200 mg once daily; increase 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 a specified time window (label).

Monitoring & Risks

Boxed warning (suicidal thoughts/behaviors): monitoring for emergent suicidality, irritability, insomnia, or unusual behavior changes is emphasized, especially early in treatment (label). Blood pressure and heart rate increases: assess at baseline, after dose increases, and periodically during therapy (label).

Somnolence and fatigue can occur, while some patients report insomnia; timing and comedications often shape tolerability (label/clinical).
Decreased appetite and nausea can occur; tracking weight, growth (pediatrics), and nutrition can be clinically useful (label/clinical).
As with other ADHD medications, clinicians commonly reassess symptom targets (school/work functioning, impulsivity, sleep) rather than relying on dose escalation alone (AAP/clinical).

Drug Interactions

Viloxazine is a strong CYP1A2 inhibitor; coadministration with sensitive CYP1A2 substrates (especially those with a narrow therapeutic range) is avoided or requires careful adjustment (label). Viloxazine is a weak inhibitor of CYP2D6 and CYP3A4; monitoring and dose adjustment of substrates may be needed when combinations are clinically necessary (label/clinical).

Because many psychiatric regimens involve multiple substrates and inhibitors, interaction review is often a deciding factor when choosing between viloxazine and other nonstimulant options (clinical).

Practice Notes

When viloxazine is chosen to avoid controlled substances, clinicians often set expectations that response is individualized and may require several weeks of consistent dosing and follow-up (clinical). Behavioral and educational supports remain foundational in ADHD care, even when medication is effective (AAP/clinical).

Medication selection often balances symptom benefit against sleep, appetite, mood, and interaction risks, with careful documentation in complex comorbidity (clinical).

References

Qelbree (viloxazine) Extended Release Capsules Prescribing Information — DailyMed (2025)
Clinical Practice Guideline FOR THE Diagnosis, Evaluation, AND Treatment OF Attention Deficit/hyperactivity Disorder IN Children AND Adolescents — Pediatrics (2019)
Attention deficit hyperactivity disorder (NICE guideline NG87) — NICE (2018)
Comparative Efficacy AND Tolerability OF Medications FOR Adhd (systematic Review AND Network Meta Analysis) — Lancet Psychiatry (2018)
AGNP Consensus Guidelines for Therapeutic Drug Monitoring in Neuropsychopharmacology — Pharmacopsychiatry (2018)