Recommended Starting Dose of Qelbree for Adults with No Significant Comorbidities
The recommended starting dose of Qelbree (viloxazine extended-release) for adults with no significant comorbidities is 200 mg once daily. 1
Dosing Regimen and Titration
- Initial dose: 200 mg once daily
- Titration: Increase by 200 mg increments at weekly intervals based on response and tolerability
- Maximum daily dose: 600 mg/day 1
This medication should be taken orally once daily, and can be administered with or without food. The pharmacokinetic profile of viloxazine ER is not significantly affected by food intake, as demonstrated by studies showing that taking it with a high-fat meal does not meaningfully alter its bioavailability 2.
Efficacy in Adults
Viloxazine ER has demonstrated significant efficacy in adults with ADHD in phase III clinical trials. In a randomized, double-blind, placebo-controlled trial, adults treated with viloxazine ER (at a mean dose of 504 mg) showed significantly greater reduction in ADHD symptoms compared to placebo as measured by:
- Adult ADHD Investigator Symptom Rating Scale (AISRS) total score
- Clinical Global Impressions-Severity of Illness (CGI-S) score
- AISRS Inattention and Hyperactivity/Impulsivity subscales 3
Many treatment effects were significant by week 2 of treatment, suggesting relatively rapid onset of action 3.
Monitoring and Side Effects
When initiating Qelbree, monitor for the following common side effects:
- Insomnia (14.8%)
- Fatigue (11.6%)
- Nausea (10.1%)
- Decreased appetite (10.1%)
- Dry mouth (9.0%)
- Headache (9.0%) 3
These side effects are generally mild to moderate in severity, with only 9.0% of adults discontinuing treatment due to adverse events in clinical trials 3.
Special Considerations
- Qelbree is a non-stimulant medication, making it a suitable option for patients who cannot tolerate stimulants or have contraindications to stimulant use 4
- Unlike stimulant medications, viloxazine does not show evidence of drug dependence, which may be advantageous for certain patient populations 4
- Machine learning analyses suggest that early response to viloxazine ER (by week 2) can predict long-term treatment efficacy with good accuracy 5
Administration Options
For patients who have difficulty swallowing capsules, Qelbree capsules can be opened and the contents sprinkled on a tablespoon of applesauce without significantly affecting the pharmacokinetics of the medication 2.
Important Precautions
While the question specifically asks about patients without significant comorbidities, it's worth noting that caution should be exercised when considering Qelbree in patients with:
- Cardiovascular conditions (monitor vital signs)
- Hepatic impairment (monitor liver function)
- History of suicidal thoughts or behaviors
- Concomitant use of MAO inhibitors (contraindicated)
Conclusion
For adults with ADHD and no significant comorbidities, starting with 200 mg once daily of Qelbree and titrating based on response and tolerability provides an effective non-stimulant treatment option with a well-characterized safety profile.