Qelbree (Viloxazine ER) Does Not Require Tapering for Discontinuation in Pediatric Patients
Based on available evidence, viloxazine extended-release can be discontinued abruptly without a formal weaning protocol, as no withdrawal syndrome has been documented in clinical trials. However, clinical monitoring for return of ADHD symptoms and mood changes is prudent during the discontinuation period.
Evidence for Abrupt Discontinuation
- No withdrawal syndrome was reported in the large-scale, long-term safety trial (N=1100) where participants discontinued viloxazine ER after up to 1896 days of exposure 1
- The phase 3 open-label extension study specifically monitored for adverse events during discontinuation transitions, and no systematic withdrawal effects emerged despite participants stopping treatment after extended use 1
- Unlike medications requiring gradual tapering (such as benzodiazepines which need 10-20% dose reductions over weeks) 2, viloxazine ER does not share pharmacological properties that necessitate weaning 1
Clinical Monitoring During Discontinuation
While tapering is not required, monitor for:
- Return of ADHD symptoms - Use ADHD Rating Scale assessments to track symptom recurrence, as efficacy diminishes once medication is stopped 1
- Mood changes - Although viloxazine ER carries a boxed warning for suicidal ideation/behavior during treatment 3, monitor using Columbia Suicide Severity Rating Scale (C-SSRS) principles during the discontinuation period 1
- Sleep pattern changes - Historical data on viloxazine showed effects on sleep architecture 4, though modern extended-release formulations report somnolence as a common side effect rather than insomnia 1
Practical Discontinuation Approach
Simply stop the medication without dose reduction. The most common scenario requiring discontinuation includes:
- Inadequate therapeutic response after appropriate dose optimization 1
- Intolerable adverse effects (somnolence, decreased appetite, headache, fatigue) 1, 3
- Patient/family preference to trial alternative ADHD treatments 3
Key Distinction from Other Medications
This differs markedly from:
- Atomoxetine - While also a nonstimulant ADHD medication, atomoxetine similarly does not require tapering 5
- Antidepressants like citalopram - These require 10-14 day tapers to prevent discontinuation syndrome 6
- Benzodiazepines - These mandate gradual 10-20% reductions to avoid withdrawal 2
Common Pitfall to Avoid
Do not confuse the need for gradual dose optimization during initiation (starting at 100-200 mg/day and titrating up over weeks) with discontinuation requirements 1. The careful upward titration prevents initial adverse effects like somnolence and gastrointestinal symptoms 5, but this principle does not apply in reverse when stopping the medication.