Rakesh Jain, MD, MPH discusses once-daily clonidine hydrochloride (ONYDA XR) for ADHD

In this Contemporary Pediatrics video interview, Rakesh Jain, MD, MPH, discussed the now-available, FDA-approved clonidine hydrochloride (ONYDA XR; Tris Pharma).

The once-a-day extended-release oral suspension with nighttime dosing, is approved to treat Attention-deficit/hyperactivity disorder (ADHD) as a monotherapy or as an adjunctive therapy to approved central nervous system (CNS) stimulant medications for patients aged 6 years and older. The oral solution was approved by the federal agency on May 29, 2024, and has been commercially available since October 1, 2024.

Clonidine hydrochloride is the first and only non-stimulant ADHD medication approved in the United States and the only approved non-stimulant ADHD medication with nighttime dosing.

"There's a lot of valuable assets this formulation has that fits nicely with the current clinical needs in psychiatry practices and pediatric practices," said Jain. "It is once a day. It is liquid, and that, of course, is really important to remember. It is to be used just once a day in a liquid formulation, and it can be used either as monotherapy, or it can be used in combination with stimulants."

For patients who do not adequately respond to stimulant medication or experience negative side effects, non-stimulant ADHD therapies are important. These treatments are increasingly used as an effective alternative to stimulant treatments, according to Tris.

According to the Centers for Disease Control and Prevention (CDC), the American Academy of Pediatrics (AAP) recommends medication and behavior therapy together for children 6 years of age and older with ADHD. The CDC stated between 70% and 80% of children with ADHD who take stimulant medications have fewer ADHD symptoms, though nonstimulants can last up to 24 hours.

I still do believe stimulant medications are to be used in probably the majority of children and adolescents, but there's a substantial minority, perhaps as many as 30%, 35%, maybe even 40% where stimulants aren't appropriate," said Jain. "They're not appropriate for a variety of reasons. They either didn't work, or there are worries about appetite suppression, or there's worry about worsening the sleep of a child who already has having trouble with it, or there's a lot of agitation, and perhaps impulsivity and behavioral challenges, and perhaps the child has symptoms throughout the day. In those situations, the stimulant just isn't adequate."

Reference:

Fitch, J. FDA approves clonidine hydrochloride to treat ADHD in patients 6 years and up. Contemporary Pediatrics. May 29, 2024. Accessed October 31, 2024. https://www.contemporarypediatrics.com/view/fda-approves-clonidine-hydrochloride-to-treat-adhd-in-patients-6-years-and-up