Maximum Dose of Qelbree for Adults
The maximum recommended dose of Qelbree (viloxazine extended-release) for adults is 600 mg once daily 1.
Dosing Details
The FDA-approved dosing for adults follows a flexible-dose approach:
- Starting dose: 200 mg once daily
- Dose range: 200-600 mg once daily
- Maximum dose: 600 mg once daily
In the pivotal adult clinical trial, the mean dose at end of study was 504 mg, indicating most patients required doses in the upper range for optimal efficacy 2. Long-term data confirm that 73% of adult patients used doses ≥400 mg/day during maintenance treatment, with 36% using the maximum 600 mg/day dose 3.
Titration Approach
Dosing should be adjusted between 200-600 mg/day based on individual response and tolerability 1. The clinical trial data show that treatment effects (including primary endpoints) were significant by week 2, suggesting relatively rapid dose optimization is appropriate 2.
Safety Considerations at Maximum Dose
At the 600 mg dose (tested in clinical trials):
- Discontinuation rate: 9% due to adverse events in the pivotal trial 2
- Most common adverse events (≥5%): insomnia (14.8%), fatigue (11.6%), nausea (10.1%), decreased appetite (10.1%), dry mouth (9.0%), and headache (9.0%) 2
- Cardiovascular monitoring: Blood pressure and heart rate should be monitored, as noradrenergic agents can cause increases 1
Important Contraindications at Any Dose
Do not exceed 600 mg, and do not use with MAOIs or within 2 weeks of MAOI discontinuation due to risk of hypertensive crisis 1. Additionally, coadministration with sensitive CYP1A2 substrates or those with narrow therapeutic ranges is contraindicated, as viloxazine is a strong CYP1A2 inhibitor 1.
Clinical Context
The 600 mg maximum dose was established through flexible-dose trials where efficacy and safety were demonstrated across the 200-600 mg range 1, 2. This represents the maximum recommended adult dose approved by the FDA, with no evidence supporting higher doses.