Qelbree Tapering Guide
viloxazine
Boxed Warning
Increased risk of suicidal thoughts and behavior in pediatric and young adult patients. Monitor closely during initial therapy and dose changes.
Overview
Viloxazine ER (Qelbree) is a non-stimulant medication approved in 2021 for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 and older. Originally developed as an antidepressant in Europe in the 1970s, it was reformulated and re-approved as an extended-release ADHD treatment.
100mg, 150mg, 200mg ER
Extended-release capsules: 100mg, 150mg, 200mg
Insufficient data — discuss with prescriber
Mechanism of Action
Selective norepinephrine reuptake inhibitor with serotonergic activity (5-HT2C receptor agonist, 5-HT2B receptor antagonist). The combined noradrenergic and serotonergic modulation is thought to underlie its efficacy in ADHD.
Taper Notes
Viloxazine ER is once-daily and generally tolerated on discontinuation, but rebound ADHD and mild dysphoria can emerge. Step down by available capsule strengths over 2–4 weeks. Strong CYP1A2 inhibition warrants review of co-medications during dose changes.
Maudsley Deprescribing Guidance
Limited published deprescribing data given recent approval (2021). Stepwise reductions by available capsule strengths over 2–4 weeks are reasonable for most patients; slow further in those with prior antidepressant withdrawal sensitivity.
Tapering Protocol
Evidence-based phased reduction schedule. Always taper under medical supervision.
| Phase | Duration | Notes |
|---|---|---|
| Initial reductions | 1-2 weeks | Step down by 100 mg increments using available capsule strengths (200 → 100 mg). |
| Final reductions | 1-2 weeks | Hold at 100 mg for several days, then discontinue. Slow further in patients with prior antidepressant withdrawal sensitivity. |
Withdrawal Timeline
1-3 days after dose reduction
3-7 days
Typically within 1-2 weeks
Rebound ADHD symptoms and irritability may persist 2-3 weeks; uncommon beyond that
Clinical Pearls
Practical considerations for clinicians supervising Qelbree tapers.
- 1Viloxazine is too new for a robust evidence base on deprescribing; clinical experience and patient observation should be documented carefully during the taper.
- 2Capsules may be opened and sprinkled on applesauce for patients with swallowing difficulty — do not chew or crush, which compromises ER kinetics.
- 3Strong CYP1A2 inhibition by viloxazine elevates levels of co-administered CYP1A2 substrates (caffeine, theophylline, tizanidine, duloxetine); expect these to fall on discontinuation and dose-adjust accordingly.
- 4Patients commonly report rebound ADHD symptoms as the predominant post-discontinuation issue; plan a successor strategy (alternative agent, behavioral support) before tapering.
Common Withdrawal Symptoms
Interactions & Safety
Drug Interactions
- MAOIs — contraindicated within 14 days
- Sensitive CYP1A2 substrates (theophylline, tizanidine, duloxetine) — viloxazine is a strong CYP1A2 inhibitor; avoid or reduce dose
- CYP2D6 substrates may have modest exposure increases
Food Interactions
- May be taken with or without food
- Capsules may be opened and sprinkled on applesauce; do not chew
Contraindications
- Concurrent or recent (within 14 days) MAOI use
- Concomitant use with sensitive CYP1A2 substrates with narrow therapeutic index
- Known hypersensitivity to viloxazine
Toxicity
Suicidal ideation in pediatric and young adult patients. Increased blood pressure and heart rate. Mild somnolence and decreased appetite are common.
Pharmacokinetics
ADME Profile
Tmax ~5 hours after oral ER administration. Bioavailability ~88%. High-fat meal reduces Cmax by ~9% and AUC by ~8%; can be taken with or without food.
~80 L
Extensively metabolized via CYP2D6 (minor) and UGT1A9/UGT2B15 to inactive 5-hydroxy-viloxazine glucuronide.
Renal (~90% as metabolites), <1% unchanged.
~76–82%
~13 L/h
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