FDA approves first non-stimulant drug for adults with ADHD in 20 years

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Key points to remember

  • For the first time in 20 years, the FDA has approved a non-stimulant drug to treat adults with ADHD.
  • It has long been assumed that most children can outgrow the condition, but many do not, although it may present differently in adults.
  • The approval opens up more non-addictive treatment options for adults with ADHD.

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

Qelbree, available as viloxazine extended-release capsules, was approved last year for pediatric patients ages 6 to 17. It is the first non-stimulant 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] the approval marks a major advance in the treatment of ADHD and is a milestone just one year after Qelbree was approved for the treatment of pediatric patients.

Approximately 16 million children, adolescents and adults in the United States suffer from ADHD, which can affect the ability to concentrate and cause hyperactivity and impulsiveness. It has long been assumed that most children can outgrow the condition, but many do not, although it may present differently in adults. There is no consensus on the percentage of people who still have ADHD as adults.

What you need to know about Qelbree

Qelbree has already been approved for use in ADHD patients as young as six years old, but has been tested separately in adults.

The Phase 3 clinical trial tested a flexible daily dose of Qelbree between 200 and 600 milligrams in adults aged 18 to 65 with ADHD. Researchers found that people treated with the drug showed “significant improvement” in inattention, hyperactivity and impulsivity scores. Patients treated with Qelbree also had less severe ADHD symptoms from the second week of treatment.

There are a range of treatments for ADHD, including behavioral therapy and medication. Medicines are generally divided 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: They were approved for the treatment of ADHD in 2003. They don’t work as quickly as stimulants, but they can last up to 24 hours.

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

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

Stimulant medications can 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 worries doctors are “overmedicating” without properly diagnosing the disease simply because the new drug is a non-stimulant.

“A six-minute visit to a primary care doctor’s office is not a thorough assessment for ADHD,” he said. “Because this drug is non-stimulant, therefore considered benign, I fear that doctors will quickly prescribe this drug.”

Still, Mayer said, “for those with an accurate diagnosis of ADHD, this might be a safer drug for the patient’s total physical health.”

How to take Qelbree

Qelbree is available by prescription for people diagnosed with ADHD. It is administered in doses ranging from 100 to 200 milligrams, taken daily with or without food.

Qelbree costs about $320 without health insurance, according to GoodRX, although the cost varies depending on insurance coverage. Qelbree costs about $20 per prescription each month with health insurance.

How does Qelbree work?

Qelbree is a non-stimulant medication that increases levels of the neurotransmitter and hormone norepinephrine in the brain. It lasts in the body for 24 hours and must be taken daily.

Accessibility and limitations of Qelbree

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

In clinical trials, rates of suicidal thoughts and behavior were higher in patients taking Qelbree than in those taking a placebo. The FDA recommends monitoring patients closely for worsening and onset of suicidal thoughts and behaviors. For this reason, Mayer said people with a history of suicidality should proceed with caution when taking this drug.

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

Known side effects

Qelbree carries the risk of several side effects:

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

If you are experiencing these side effects and they are interfering with your quality of life, talk to your doctor about next steps.

What this means for you

Qelbree’s approval for use in adults opens up more options for treating ADHD. If you have ADHD and want to use non-stimulant medication, ask your doctor if Qelbree is right for you.

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