Qelbree, approved by the U.S. Food and Drug Administration (FDA) in May 2021, is a medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6 to 17 years and adults [1]. It is available by prescription only [1].
How does Qelbree work for ADHD?
Qelbree is classified as a selective norepinephrine reuptake inhibitor (SNRI) [1]. It works by increasing the levels of norepinephrine, a neurotransmitter, in the brain [1]. Norepinephrine plays a role in regulating attention, impulsivity, and hyperactivity, which are core symptoms of ADHD [1][2]. Unlike stimulant medications commonly used for ADHD, Qelbree is a non-stimulant [1].
What are the potential side effects of Qelbree?
Common side effects reported with Qelbree include insomnia, nausea, decreased appetite, fatigue, vomiting, and irritability [1]. Serious side effects can include suicidal thoughts and behaviors, and Qelbree may also increase blood pressure and heart rate [1][3]. Patients should be monitored for changes in mood and behavior, as well as cardiovascular status [1][3].
When can I expect Qelbree to become available as a generic?
The patent for Qelbree is held by Shionogi Inc. and has an expiration date of November 20, 2036 [4]. Generic versions of Qelbree are not expected to be available until after this patent expires, barring any successful patent challenges or early settlements [4].
Are there other non-stimulant ADHD medications available?
Yes, several other non-stimulant medications are approved for the treatment of ADHD. These include atomoxetine (Strattera), guanfacine extended-release (Intuniv), and clonidine extended-release (Kapvay) [5]. Each of these medications works through different mechanisms and may have varying side effect profiles and efficacy [5].
How does Qelbree compare to stimulant ADHD medications?
Stimulant medications, such as methylphenidate and amphetamine products, are often considered first-line treatments for ADHD due to their generally rapid onset of action and high efficacy [6]. Non-stimulants like Qelbree may be an alternative for individuals who do not tolerate stimulants well, have contraindications to stimulants, or for whom stimulants have not been effective [6]. Qelbree's mechanism of action, focusing on norepinephrine, differs from stimulants, which primarily affect dopamine and norepinephrine [1][2].
What clinical data supports Qelbree's use in ADHD?
Qelbree's approval was based on data from clinical trials involving children and adults with ADHD. These trials demonstrated a statistically significant reduction in ADHD symptoms compared to placebo [1]. Further details on specific trial outcomes and efficacy measures are available in prescribing information [1].
Where can I find more information about Qelbree and ADHD treatment?
Information regarding Qelbree, its prescribing details, and potential patent expiration dates can be found on DrugPatentWatch.com [4]. For comprehensive medical advice and treatment options for ADHD, consulting with a healthcare professional is recommended [1].
Sources:
[1] https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213453s016lbl.pdf
[2] https://www.drugpatentwatch.com/drug/qelbree
[3] https://www.mayoclinic.org/drugs-supplements/qelbree-oral-route/proper-use/drh-20529014
[4] https://www.drugpatentwatch.com/drug/qelbree
[5] https://www.additudemag.com/adhd-medication-stimulant-non-stimulant-list/
[6] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3002494/