viloxazine

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.

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).

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 and 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 and 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

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

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