Qelbree: Nonstimulant ADHD Medication
Qelbree is a nonstimulant ADHD medication approved by the FDA to treat symptoms in patients 6 to 17 years of age.
What is Qelbree?
Qelbree (i.e. SPN-812) is a nonstimulant ADHD medication containing a serotonin norepinephrine modulating agent approved by the FDA to treat attention deficit hyperactivity disorder (ADHD or ADD) in patients 6 to 17 years of age. Its active ingredient, viloxazine hydrochloride, was previously marketed as an antidepressant in Europe. It is the first nonstimulant ADHD medication to receive FDA approval for use in children since Intuniv was approved in 2009.
Qelbree Dosages Explained
For patients 6 to 11 years of age, the recommended starting dosage of Qelbree is 100 mg once daily. This may be titrated in increments of 100 mg weekly to the maximum recommended dosage of 400 mg once daily. The recommended starting dosage for patients 12 to 17 years of age is 200 mg once daily. This may be titrated after 1 week, by an increment of 200mg, to the maximum recommended dosage of 400 mg once daily.
Qelbree capsules can be swallowed whole or opened and sprinkled onto food. Do not cut, crush, or chew the capsules.
What Are the Side Effects of Qelbree?
Qelbree can increase diastolic blood pressure and heart rate. These measures should be assessed before to starting treatment, following increases in treatment, and periodically during treatment.
Other commonly observed side effects of Qelbree include:
- drowsiness or somnolence
- decreased appetite
- trouble sleeping
Increased Risk of Suicidal Thoughts Associated with Qelbree
Qelbree may increase suicidal thoughts and actions in some children with ADHD, especially within the first few months of treatment or when the dose is changed. Caregivers should closely monitor any new or sudden changes in mood or behavior, and call the child’s doctor immediately if there are any new or sudden changes, or if there is development of suicidal thoughts or actions.
Qelbree and Mania or Hypomania in Patients with Bipolar Disorder
Noradrenergic drugs may induce a manic or mixed episode in patients with bipolar disorder. Before starting Qelbree, patients should be screened for bipolar disorder. Screening should include a detailed psychiatric history, including a personal or family history of suicide, bipolar disorder, and depression.
Qelbree and Somnolence or Fatigue
Activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, should be avoided until the patient knows how they will be affected by Qelbree.
Interactions Associated with Qelbree
Patients that take certain anti-depression medicines, especially those called a monoamine oxidase inhibitor or MAOI, or certain asthma medicines, should not take Qelbree.
Qelbree is a strong CYP1A2 inhibitor. Coadministration with moderately sensitive CYP1A2 substrates, such as clozapine and pirfenidone, is not recommended. Qelbree is a weak inhibitor of CYP2D6 and CYP3A4, which increases exposure of those substrates, such as dextromethorphan and alfentanil, when coadministered with Qelbree.
More Information on Qelbree and Other ADHD Medications:
“Supernus Announces FDA Approval of Qelbree™ (SPN-812) for the Treatment of ADHD.” Supernus Pharmaceuticals, Inc. (April 2021) https://ir.supernus.com/news-releases/news-release-details/supernus-announces-fda-approval-qelbreetm-spn-812-treatment-adhd
Qelbree label. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211964s000lbl.pdf
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