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Qelbree

Pronunciation: Kel’ bree
Generic name: viloxazine
Dosage form: capsules (100 mg, 150 mg, 200 mg)
Drug class: Adrenergic uptake inhibitors for ADHD

Medically reviewed by Melisa Puckey, BPharm. Last updated on Mar 28, 2024.

What is Qelbree?

Qelbree is a once-a-day treatment for attention deficit hyperactivity disorder (ADHD) in adults and children 6 years of age and older. Qelbree is a non-stimulant ADHD medicine that may help to improve attention and reduce hyperactivity and impulsiveness.

Qelbree is thought to work by increasing levels of norepinephrine, a chemical messenger found in the brain, by blocking a protein called pre-synaptic norepinephrine transporter. ADHD has been associated with low levels of norepinephrine, leading to symptoms such as hyperactivity, impulsivity, and lack of attention, so increasing norepinephrine levels may reduce ADHD symptoms. Qelbree is classified as a selective norepinephrine reuptake inhibitor (SNRI). 

Qelbree’s FDA approval was received on April 2, 2021, and it is now indicated for the treatment of ADHD in adults and pediatric patients 6 years and older. Qelbree contains the active ingredient (which is sometimes referred to as the generic name) viloxazine.

Qelbree side effects

Common Qelbree side effects

Common Qelbree side effects in adults are trouble sleeping, headache, sleepiness, tiredness, nausea, decreased appetite, dry mouth, and constipation. 

Common Qelbree side effects in pediatric patients are sleepiness, decreased appetite, tiredness, nausea, vomiting, trouble sleeping, and irritability.

These common side effects occurred in 5% or more of patients, at least twice the rate of patients taking a placebo.

Serious Qelbree side effects

Get emergency medical help if you have signs of an allergic reaction, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have symptoms of a manic episode. Manic symptoms include racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, or being agitated or talkative.

This medicine can affect weight in children. Tell your doctor if your child loses weight or is not gaining weight at a normal rate.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Qelbree side effects (more detail)

Warnings

Some people have thoughts about suicide while taking  this medicine, especially within the first few months of treatment or when the dose is changed. Stay alert to changes in your or your child's mood or symptoms. Report to your healthcare provider right away if there are any sudden changes in mood, behavior, thoughts, or feelings or if you or your child develops suicidal thoughts or actions.

See the Side Effects section for more information about side effects.

Before taking this medicine

Some drugs should not be used with Qelbree. Your treatment plan may change if you also use:

Do not use this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

Tell your doctor if you or anyone in your family has ever had:

Tell your doctor if you have ever had:

Pregnancy

Qelbree may be harmful when taken during pregnancy. Tell your doctor right away if a pregnancy occurs.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of viloxazine on the baby and the mother.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or planning to breastfeed, as it is not known if Qelbree passes into breastmilk. Ask to your healthcare provider about the best way to feed the baby during treatment with this medicine.

Qelbree pregnancy and breastfeeding warnings (more detail)

How should I take Qelbree?

Qelbree directions: Qelbree capsules are taken once a day, with or without food. Swallow the capsule whole, and do not crush, chew, break, or open it. If you cannot swallow a capsule whole, open it and mix the medicine with applesauce. Swallow the mixture right away without chewing.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Your heart rate and blood pressure will need to be checked often.

Qelbree dosing information

Usual Pediatric Qelbree Dose for Attention Deficit Disorder:

6 to 11 years
Initial dose: 100 mg orally once a day
Dose increases: May titrate in increments of 100 mg per week based on response and tolerability
Maximum dose: 400 mg/day

12 to 17 years
Initial dose: 200 mg orally once a day
Dose increases: After 1 week, may titrate to 400 mg once a day based on response and tolerability
Maximum dose: 400 mg/day

Usual Adult Qelbree Dose for Attention Deficit Disorder:

Adult patients: 
Initial dose: Recommended starting dosage is 200 mg once daily. 
Dose increases: May titrate in increments of 200 mg weekly to maximum recommended dosage of 600 mg once daily
Maximum dose: 600 mg/day

Comments:

Qelbree is available in Extended-release capsules: 100 mg, 150 mg, and 200 mg.

Detailed Qelbree dosage information

What should I avoid while taking Qelbree?

Do not drive or operate heavy machinery until you know how this medicine will affect you. Qelbree may cause you to feel sleepy or tired.

What other drugs will affect Qelbree?

Tell your healthcare provider about all the medicines you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Qelbree and other medicines may affect each other, causing possible serious side effects.

Your healthcare provider will decide if Qelbree can be taken with other medicines.

Especially tell your healthcare provider if you or your child take:

Know the medicines you or your child takes. Keep a list of them and show it to your healthcare provider and pharmacist when you or your child gets a new medicine.

Do not start any new medicine during treatment with Qelbree without first talking to your healthcare provider.

Not all possible interactions are listed here. For more information on interactions with Qelbree, click on the link below.

Qelbree drug interactions (more detail)

Ingredients

Active ingredient: viloxazine

Inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, corn starch, ethylcellulose, FD&C Blue #1, FD&C Red #28, FD&C Yellow #5, FD&C Yellow #6, FD&C Yellow #10, gelatin, hypromellose, isopropyl alcohol, lactose monohydrate, medium chain triglycerides, oleic acid, polyethylene glycol, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, sucrose, talc, triacetin, titanium dioxide.

Storage

Company 

Manufactured by: Catalent Pharma Solutions, LLC, 1100 Enterprise Drive, Winchester KY 40391, USA.
Distributed by: Supernus Pharmaceuticals, Inc., Rockville, MD USA 20850.

Popular FAQ

Qelbree is thought to work by blocking the reuptake and raising levels of norepinephrine, a chemical messenger found in the brain. It is classified as a selective norepinephrine reuptake inhibitor (SNRI). ADHD has been associated with low levels of norepinephrine leading to symptoms such as hyperactivity, impulsivity, and lack of attention.

Qelbree works in as little as 1 to 2 weeks with trials showing significant reductions in ADHD symptoms in children aged 6 to 11 years by 1 week, and those aged 12 to 17 years by week 2. Mean changes in baseline ADHD-RS-5 Total Scores of -16 to -17.7 to were reported across 3 studies after 6 weeks.

Qelbree is an extended-release tablet and one single daily dose provides 24-hour coverage.

In some people, Qelbree reduces the frequency and severity of ADHD symptoms (including inattention, hyperactivity, and impulsivity) in as little as 1 week. Clinical trials have reported a significant reduction in ADHD symptoms scores:

  • At 1 week for children aged 6 thru 11 years taking 100mg and 200mg doses
  • At 2 weeks for adolescents aged 12 thru 17 years taking 400mg doses.

Some patients may take up to 6 weeks to respond to Qelbree.

Qelbree is taken once a day and lasts for 24 hours. It is usually prescribed for months to years, although you can ask your doctor for a trial off medication at any time to see if you can manage without it.

Qelbree and Strattera are both oral nonstimulant medicines shown in clinical studies to be effective in treating ADHD in children 6 years and older and adults. They are not controlled substances. Strattera is available as generic option known as atomoxetine, which may save you money. Continue reading

Qelbree (viloxazine ER) and Adderall (mixed amphetamine salts) are oral medications used to treat attention deficit hyperactivity disorder (ADHD) in adults and children. Differences are that Qelbree is a long-acting, once daily nonstimulant medicine and is less likely to cause trouble with sleeping or lead to abuse. Adderall is a short-acting stimulant medication given 1 to 3 times a day, is a C-II controlled substance, and can be abused.

Continue reading

References

  1. Qelbree Package Insert FDA

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer