Viloxazine
QELBREE
What it isNorepinephrine-reuptake inhibitor with serotonergic activity; ADHD.
Why this oneIt is a noncontrolled ADHD treatment with serotonergic activity that atomoxetine lacks.
What limits itStrong CYP1A2 inhibition can sharply raise clozapine or theophylline exposure; somnolence and suicidality also matter.
FDA-approved for
- ADHD (2021)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| ADHD | pediatric 6-11y | 100 mg QD | titrate to response | 400 mg QD |
| ADHD | pediatric 12-17y | 200 mg QD | titrate to response | 400 mg QD |
| ADHD | adult | 200 mg QD | titrate to response | 600 mg QD |
Titration Increase at weekly intervals (100 mg peds 6-11y; 200 mg peds 12-17y and adults)
Renal Severe (eGFR <30): start 100 mg QD, titrate weekly by 50-100 mg to max 200 mg QD
Hepatic Undefined
Instructions
- Swallow capsule whole or open and sprinkle contents onto applesauce/pudding
- Assess heart rate and blood pressure before and during treatment
- Screen for suicide, bipolar disorder, depression before starting
Contraindications
- MAOIs (concurrently or within 14 days) due to risk of hypertensive crisis
- Sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range
Cautions
- Blood pressure and heart rate increases
- Activation of mania/hypomania
- Somnolence and fatigue
Adverse reactions
- Somnolence
- Decreased appetite
- Fatigue
- Nausea
- Vomiting
- Insomnia
- Irritability
- Headache
- Dry mouth
- Constipation
Pregnancy May cause maternal harm; discontinue when pregnancy is recognized unless benefit outweighs risk
Lactation Low transfer into breastmilk (relative infant dose ~1%)
⚠ BOXED WARNING
- Suicidal thoughts and behaviors in patients under 25
Cost, est. cash$300–$2,500/month
Generic entry2033 est.
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilitySomnolence or activation, blood-pressure effects and suicidal-thinking warning in younger patients.
Mechanism of action: Viloxazine ballicule
Open Viloxazine in the interactive console ↗
Memory aids: mascots and interaction avatars
CYP1A2 inHibitor
