Qelbree (tranylcypromine) has not received FDA approval for the treatment of ADHD in adults. The U.S. Food and Drug Administration (FDA) approved Qelbree in December 2020 for the treatment of ADHD in pediatric patients aged 6 to 17 years [1][2].
What is Qelbree used for?
Qelbree is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients aged 6 to 17 years. It is a prescription medication taken orally once daily [1][3].
When was Qelbree approved for children?
Qelbree received FDA approval for the treatment of ADHD in pediatric patients on December 2, 2020 [1][2].
Is Qelbree available for adults?
As of its FDA approval in December 2020, Qelbree was not approved for adult ADHD [1][2]. Information on any subsequent trials or applications for adult use is not provided.
How does Qelbree work?
Qelbree is a selective and reversible inhibitor of monoamine oxidase type B (MAO-B) and monoamine oxidase type A (MAO-A). By inhibiting these enzymes, Qelbree is thought to increase the levels of certain neurotransmitters in the brain, such as dopamine, norepinephrine, and serotonin, which are believed to play a role in ADHD [4].
What are the potential side effects of Qelbree?
The most common side effects reported in clinical trials for Qelbree in pediatric patients included somnolence, decreased appetite, insomnia, nausea, vomiting, headache, and upper abdominal pain [1]. Qelbree carries a boxed warning regarding the risk of suicidal thoughts and behaviors, and requires careful monitoring of patients for any emergence or worsening of depression, suicidal thoughts or behaviors, or unusual changes in behavior [1][5].