New Medication Approved for ADHD

Qelbree (viloxazine), approved by the FDA on April 2, 2021, is a non-stimulant medication used to treat ADHD in children between the ages of 6 and 17. It comes in once-daily tablets of 100 mg, 150 mg, or 200 mg and has the added advantage of not being a controlled substance, making it harder to abuse and more effortless to renew prescriptions.

New medication for children with ADHD

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Viloxazine was first used in the United Kingdom during the 1970s to treat depression; It was not approved in the United States, although allowed for cataplexy and narcolepsy with an orphan designation. In 2002, it was discontinued due to business reasons. Supernus Pharmaceuticals began developing formulations of the drug for the treatment of ADHD in 2015.

Study Results

In a late-stage study, 477 children between the ages of 6 and 11 took the medication daily for six weeks. The researchers found the children had a 50% reduction of inattention and hyperactivity symptoms compared to placebo. Symptoms began to decrease in as little as one week. Another study, with more than 1,000 participants between 6 and 17 years old found more significant reductions in ADHD symptoms as compared with a placebo.

Side Effects

According to the studies, Qelbree is well-tolerated, and there is a low occurrence of adverse events.

The most common side effects include drowsiness, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability.

The medication can cause an increase in heart rate and blood pressure.

People with a history of mental illness should discuss the risks and benefits with their doctor as the medication could induce mania or mixed episodes.

Warnings

There is a boxed warning on Qelbree because of higher rates of suicidal thoughts and behavior, which is more common during the first few months of treatment or when the dosage is changed. Parents and caregivers should pay attention to changes in moods, behavior, thoughts, and feelings and contact their doctor immediately.

Children taking monoamine oxidase inhibitors (MAOI) currently or within 14 days should not take Qelbree. The interactions between these two drugs can cause a hypertensive crisis.

Suggested Dosage

The prescribing information for Qelbree for children between six and 11 years old is an initial dose of

100 mg daily to be increased by 100 mg each week if needed to a maximum of 400 mg daily.

For adolescents and teens between 12 and 17 years of age, the dosage is 200 mg daily initially and one additional increment of 200 mg, if needed, to a maximum of 400 mg.

Considerations Before Starting Qelbree

Whether you are considering Qelbree as an initial medication for your child or thinking about changing from a different drug, you should discuss the risks and benefits with your child’s doctor. The following are questions you can ask before making a decision:

• How does this medication work in the brain?
• What changes in symptoms should you expect?
• What are the side effects? What potential side effects should you be aware of, which should prompt a call to the doctor, and which ones constitute an emergency and require immediate medical help?
• How often will my child need to have doctor’s appointments to monitor the medication?
• When should I expect to see changes? How will I know if the medication is working?
• How and when should the medication be taken?
• Are there foods that can interfere with the drug’s effectiveness that we should avoid?
• Is this medication taken every day or as needed?
• What is involved in stopping the medication?