- The Food and Drug Administration has approved Qelbree, a new non-stimulant medication for children with attention deficit hyperactivity disorder (ADHD).
- Experts say there are a limited number of non-stimulant treatments available for children with ADHD.
- They say non-stimulants are less addictive, have fewer side effects, and are easier to refill.
This medication, which will be marketed under the brand name Qelbree, is an extended-release capsule that can be sprinkled on food for easy consumption.
The FDA has approved the drug for children 6 to 17 years of age.
ADHD is a mental health disorder typified by hyperactive and impulsive behaviors, trouble focusing attention on single tasks, and difficulty sitting still for long periods of time.
About 6.1 million American children have an ADHD diagnosis, according to the Centers for Disease Control and PreventionTrusted Source (CDC).
However, experts say treatment options are limited.
“There is a misconception that this is an area overcrowded with treatment options, when the majority of the current options are a reformulation of just two stimulant molecules, methylphenidate and amphetamine,” said Dr. Andrew J. Cutler, a clinical associate professor of psychiatry at SUNY Upstate Medical University and chief medical officer at the Neuroscience Education Institute, and who consulted on the Qelbree trial.
“Some patients don’t respond to or tolerate available medications. There is, therefore, an unmet medical need, and I think it is very exciting to have a new non-stimulant medication option such as Qelbree to offer to my child and adolescent patients with ADHD,” he said.
There are currently around 30 stimulant medications prescribed to treat ADHD, but only four non-stimulants, Cutler told Healthline.
Qelbree is the first newly approved non-stimulant for ADHD treatment in a decade.
Non-stimulant ADHD medications operate essentially in reverse to more traditional stimulant medications, Dr. Jeffrey S. Ditzell, a psychiatrist based in New York City, told Healthline.
“ADHD treatments, most notably the stimulant medications, such as Adderall or Ritalin, work to increase norepinephrine and dopamine by facilitating their release and blocking their reuptake in the brain, which can improve concentration, attention, executive functioning, and wakefulness,” he said. “This medication works by inhibiting the reuptake of norepinephrine, though the medication’s mechanism of action, or the manner in which it exerts its effects in ADHD, remains unclear.”
In addition to being controlled substances with the potential for addiction or misuse, stimulant medications simply don’t work for all people, making the debut of drugs such as Qelbree all the more important.
“One problem I’ve seen in my practice is the limited available medication options when treating ADHD, especially those with comorbid disorders such as anxiety, bipolar disorder, or substance use disorder,” Marci Bastien, DNP, PMHNP-BC, a psychiatric nurse practitioner, at Community Psychiatry in Del Mar, California, told Healthline.
“The use of psychostimulants can actually worsen mood symptoms, increase irritability, agitation, and even induce a manic response. Psychostimulants are not recommended for patients with a comorbid substance use disorder to avoid abuse or dependency. Other medical conditions such as seizure disorder, cardiac disorder, or other medical conditions can further limit medication options,” she said.
Non-stimulant drugs have other benefits as well.
“They’re not controlled medications, making it easier for patients to access this medication and obtain refills and are not as activating, and thus can work for longer periods of time without causing side effects like insomnia and anxiety, which are often an issue with stimulant medications,” Dr. Pavan Madan, another psychiatrist at Community Psychiatry, told Healthline.
“Qelbree has been shown to work relatively quickly, within the first one-to-two weeks, with straightforward dosing,” he said.