PharmaceuticalNon-stimulant ADHD agentNorepinephrine reuptake inhibitorSNMA

Viloxazine

Also known as Qelbree · Vivalan · SPN-812

Written by enwyReviewed 5 Aug 20262 sources0 comments

Viloxazine (Qelbree) is a non-stimulant norepinephrine reuptake inhibitor with serotonergic modulation, re-purposed from a discontinued antidepressant and approved in 2021 for ADHD in children, adolescents and adults. It offers a non-controlled alternative to stimulants with efficacy demonstrated in placebo-controlled trials.

01 Overview

Originally marketed as the antidepressant Vivalan in the 1970s-80s, viloxazine was reformulated as an extended-release ADHD treatment. Pivotal trials showed significant reductions in ADHD-RS-5 total scores versus placebo across paediatric and adult populations.

It is not a controlled substance and lacks meaningful abuse liability, but carries a boxed warning for suicidal ideation typical of the class and is a strong CYP1A2 inhibitor, creating relevant drug interactions (e.g. with caffeine).

02 Mechanism

Norepinephrine reuptake inhibitor with additional serotonergic activity (5-HT2B antagonism, 5-HT2C agonism) that modulates prefrontal noradrenergic and serotonergic signalling.

03 Dosing

Tier	Dose	Route	Notes
Paediatric	100–400 mg/day	Oral	Children 6-11: start 100 mg/day, titrate weekly to max 400 mg.

04 Effects

Effect	Magnitude	Evidence
Reduced ADHD symptomsImprovement in inattention and hyperactivity-impulsivity versus placebo, often within 1-2 weeks.	-8 to -17 ADHD-RS-5 points	Clinical
Non-euphoric focusCognitive/attentional benefit without the reinforcing subjective effects of stimulants.	n/a	Clinical

05 Side effects

Effect	Severity	Frequency	Evidence
Somnolence and fatigueSleepiness, fatigue and lethargy, especially early in treatment.	Mild	Common	Clinical
Suicidal ideationIncreased risk of suicidal thoughts, a class effect carrying a boxed warning.	Severe	Boxed warning	Clinical
CYP1A2 interactionStrong CYP1A2 inhibition raises levels of substrates such as caffeine, theophylline and duloxetine.	Moderate	Interaction	Clinical

06 Legal status

United States

Rx (not scheduled)

FDA-approved (Qelbree) for ADHD; non-controlled. · as of Jan 2026

07 References

Efficacy and Safety of Viloxazine ER in Children with ADHDClin Ther / J Child Adolesc Psychopharmacol, 2021

Qelbree (viloxazine) FDA prescribing informationUS FDA, 2021

08 Discussion0 comments

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This page is reference information, not medical advice. Doses and protocols are documented as they appear in the clinical literature and in practice — describing them is not a recommendation to use them. Countermeasures listed here are not a substitute for a physician. Legal status varies by jurisdiction and changes.