From the Guidelines
The recommended dosing for Quelbree (viloxazine) is to start with 200 mg orally once daily, with titration by 200 mg increments at weekly intervals based on response and tolerability, up to a maximum daily dose of 600 mg/d. This dosing regimen is based on the most recent evidence available, as reported in the study published in the American Journal of Obstetrics and Gynecology in 2024 1.
Key Considerations
- The study notes that viloxazine could be considered as an agent in the treatment of ADHD following a risk-benefit discussion, acknowledging that there is no information published on its safety in pregnancy and there is limited data on its efficacy for the treatment of ADHD in adults 1.
- Alternative agents would be preferred due to the limited data available on viloxazine's safety and efficacy in certain populations 1.
- It is essential to monitor patients closely, especially those with a history of suicidal thoughts or behaviors, as viloxazine may carry risks similar to other ADHD medications.
Dosing and Administration
- The dose should be titrated based on response and tolerability, with a maximum daily dose of 600 mg/d 1.
- The medication should be taken orally, once daily, with or without food, at the same time each day.
- Abruptly stopping the medication should be avoided, as this may cause withdrawal symptoms.
Important Safety Information
- Patients should be closely monitored for potential side effects, including decreased appetite, insomnia, headache, and irritability.
- Viloxazine's safety in pregnancy and breastfeeding has not been established, and its use in these populations should be approached with caution 1.
From the FDA Drug Label
8.6 Renal Impairment Dosage reduction is recommended in patients with severe (eGFR of < 30 mL/min/1.73m 2[MDRD]) renal impairment [see Dosage and Administration (2. 4)] .
The FDA drug label does not answer the question.
From the Research
Recommended Dosing for Quelbree (Viloxazine)
- The recommended dosing for Quelbree (viloxazine) is as follows:
- Initiation at 200 mg/day and adjustment (between 200 and 600 mg/day) to achieve optimal efficacy and tolerability 2
- Most participants (73%) used viloxazine ER doses ≥ 400 mg/day, with 36% using doses of 600 mg/day 2
- A mean viloxazine ER dose of 504 mg was used in a phase III, randomized, double-blind, placebo-controlled trial in adults with attention-deficit/hyperactivity disorder 3
- Key considerations for dosing:
- Studies have demonstrated the efficacy and safety of viloxazine ER in pediatrics (6-17 years of age) and adults with attention-deficit/hyperactivity disorder 4, 3, 5, 6