Qelbree is a nonstimulant ADHD medication approved by the FDA to treat symptoms in adults and children over 6.
Generic Name: viloxazine
What is Qelbree?
Qelbree (Generic Name: viloxazine) is a non-stimulant ADHD medication containing a serotonin norepinephrine modulating agent approved by the FDA to treat attention deficit hyperactivity disorder (ADHD or ADD) in adults and children over six years of age. Its active ingredient, viloxazine hydrochloride, was previously marketed as an antidepressant in Europe. It is the first non-stimulant ADHD medication to receive FDA approval for use in children since Intuniv was approved in 2009.
Qelbree Dosages Explained
Qelbree is available in 100mg, 150mg and 200mg dosages. 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. The recommended starting dosage for adults is 200 mg once daily. This may be titrated in increments of 200 mg weekly, to maximum recommended dosage of 600 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 patients, especially within the first few months of treatment or when the dose is changed. Closely monitor any new or sudden changes in mood or behavior, and call your 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.
Studies on Qelbree
Data from two studies presented by Qelbree’s manufacturer, Supernus Pharmaceuticals, Inc., at Psych Congress 2023 showed improved efficacy in children aged six and older with ADHD when Qelbree was added to a stimulant, as well as in adults with ADHD who undergo long-term treatment with the medication.1
An eight-week, Phase IV, open-label study found that when added to existing psychostimulants, Qelbree demonstrated a favorable safety and tolerability profile and improvement in ADHD symptoms in pediatric patients (6-17 years), regardless of the timing of dosing. For the study, children (ages 6-11) and adolescents (ages 12-17) took psychostimulants at least five days a week in the morning. They received Qelbree once daily in the morning through week four and then switched to evening dosing through week eight; children received 100mg per day of Qelbree at week one and were optimized to 100-400mg per day, and adolescents received 200mg per day of Qelbree at week one and were optimized to 200-600mg per day.
Results showed significant symptom improvement from baseline ADHD-RS-5 and CGI-S scores following both morning and evening dosing of Qelbree in combination with the morning psychostimulant. At baseline (N=56), mean (standard deviation) ADHD-RS-5 and CGI-S scores were 37.2 (8.35) and 4.4 (0.56), respectively, and improved at week four (N=54) by -13.5 (9.7) and -0.9 (0.92), respectively, and at week eight (N=48) by -18.2 (9.99) and -1.4 (1.10), respectively. Reported adverse events of the combination therapy included headache (17.9%), decreased appetite (12.5%), and upper respiratory tract infection (10.7%), and 3.6% of patients discontinued the combination treatment due to an AE.
The results from a long-term, open-label extension (OLE) trial of the double-blind pivotal Phase III study that led to the U.S. Food and Administration (FDA)-approval of Qelbree in adults with ADHD found that adult patients (N=159) saw improvement in ADHD symptoms and executive function with safety and tolerability similar to the initial trial.
For the study, adults received 200mg of Qelbree daily for one week, increased to 400mg, and optimized over twelve weeks up to 600mg per day (200-600mg per day). Patients in this open-label trial received Qelbree for 265 (254.9) days.
Patients ADHD symptoms improved from 37.9 (6.34) to 19.7 (12.16) on the Adult ADHD Investigator Symptom Rating Scale (AISRS), representing average symptom reduction of -18.2 (11.54). Patients executive function improved from 70.4 (10.94) to 58.3 (16.19) on the BRIEF-A Global Executive Composite scale, representing an improvement in executive function of -12.9 (13.48). Reported AEs were consistent with those seen in the short-term pivotal adult trial. The most commonly occurring AEs with the use of Qelbree were insomnia (11.3%), nausea (9.4%), headache (5.7%), and fatigue (10.1%). AEs led to discontinuation in 17.6% of patients.
Qelbree and Other ADHD Medications: More Information
- Read: A Parent’s Guide to ADHD Medications
- Read: FDA Approves New Nonstimulant ADHD Medication from Supernus Pharmaceuticals
- Download: Take Charge of Your Child’s Medication
- Download: How Do We Know the Medication Is Working?
- Find: ADHD Specialists or Clinics Near You
View Article Sources
1“Supernus Announces New Qelbree® Data Showing Improvement in ADHD Symptoms.” Supernus Pharmaceuticals, Inc. (September 2023) https://ir.supernus.com/news-releases/news-release-details/supernus-announces-new-qelbreer-data-showing-improvement-adhd
“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