FDA Approves the First Nonstimulant Medication for Adults With ADHD in 20 Years

The Food and Drug Administration (FDA) has approved Qelbree, a nonstimulant medication, to treat adults with attention-deficit hyperactivity disorder (ADHD).

Qelbree, available in viloxazine extended-release capsules, was approved for pediatric patients aged six to 17 last year. This is the first nonstimulant prescription ADHD medication approved for adults in 20 years.

The approval is based on positive results from a Phase 3 clinical trial of Qelbree in adults.

“We are fully committed to better understanding how to treat complex diseases such as ADHD,” Jack Khattar, president and CEO of Supernus Pharmaceuticals, the company that makes Qelbree, said in a statement. “[The] approval marks a major advancement in the treatment of ADHD and is an important milestone just one year after the approval of Qelbree to treat pediatric patients.”

Roughly 16 million children, teens, and adults in the U.S. have ADHD, which can affect the ability to focus and cause hyperactivity and impulsiveness. It was long assumed that most children may outgrow the condition, but many don’t, though it may present differently in adults. There isn’t a consensus on what percentage of people still have ADHD as adults.

What to Know About Qelbree 

Qelbree was previously approved for use in ADHD patients as young as six, but was tested separately in adults.

The phase 3 clinical trial tested a daily flexible dose of Qelbree between 200 to 600 milligrams in adults aged 18 to 65 with ADHD. Researchers found that those treated with the medication had a “significant improvement” in inattention, hyperactivity, and impulsivity scores. The patients treated with Qelbree also had less severe symptoms of ADHD, starting at week two on the medication.

There is a range of treatments for ADHD, including behavioral therapy and medications. Medications are generally broken into the following categories:

• Stimulants: These are the most widely used ADHD medications. Up to 80% of children with ADHD have fewer symptoms when taking these medications.
• Nonstimulants: These were approved for the treatment of ADHD in 2003. They don’t work as fast as stimulants, but they can have an impact for up to 24 hours.

The approval of Qelbree for adults opens up more options for adults, Gail Saltz, MD, a clinical associate professor of psychiatry at The New York Presbyterian Hospital, told Verywell Health.

“There is a need for medication options for adults, especially nonstimulant, non-addictive medications,” she said. “Stimulants can be very effective, but they are a controlled substance and concerns of abuse can arise.”

Stimulant medications may also be difficult for some people to take, including those who also have an anxiety disorder, Saltz said.

Clinical psychologist John Mayer, PhD, said he is concerned that doctors will be “over-medicating” without properly diagnosing the condition simply because the new drug is a nonstimulant.

“A six-minute primary care physician office visit is not a thorough evaluation for ADHD,” he said. “With this medication being nonstimulant—therefore seen as benign—I fear that physicians will be quick to prescribe this medication.”

Still, Mayer said, “for those accurately diagnosed with ADHD, this could be a safer medication for the total physical health of the patient.”

How to Take Qelbree

Qelbree is available by prescription for people with a diagnosis of ADHD. It’s given in doses ranging from 100 to 200 milligrams, taken daily with or without food.

Qelbree is around $320 without health insurance, according to GoodRX, although the cost will vary with insurance coverage. Qelbree costs about $20 per prescription each month with health insurance.

Accessibility and Limitations of Qelbree

Qelbree has only been approved for patients who are at least six years old.

In clinical trials, there were higher rates of suicidal thoughts and behavior in patients on Qelbree than those who took a placebo. The FDA recommends closely monitoring patients for worsening and emerging suicidal thoughts and behaviors. Because of this, Mayer said that people with a history of suicidality should proceed with caution when taking this medication.

Patients should not take Qelbree if they are already on certain antidepressants, including monoamine oxidase inhibitors (MAOIs), or certain asthma medicines.

Known Side Effects

Qelbree comes with the risk of several side effects:

• Insomnia
• Headache
• Drowsiness
• Fatigue
• Nausea
• Decreased appetite
• Dry mouth
• Constipation

If you experience these side effects and they are interfering with your quality of life, discuss with your doctor about the next steps.