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Results with Qelbree

Qelbree is a non-stimulant treatment for ADHD in children ages 6-17 that is effective all day. Qelbree has been proven effective and safe* in clinical trials, and may be the right treatment option for your child.

*Important: Monitor your child for mood or behavior changes. Your child’s doctor may also monitor for changes in blood pressure and heart rate.

Proven results

Safety profile

Qelbree is proven to significantly reduce ADHD symptoms in 3 clinical trials

In clinical studies, Qelbree—a non-stimulant—was proven to help effectively manage ADHD symptoms.

Rapid and extended release for full-day coverage.

By reducing the impact of ADHD symptoms, Qelbree can help improve your child's difficult behavior related to ADHD. Qelbree met the goal of 3 different clinical trials – a significant reduction in ADHD symptom scores in 6 weeks. For some patients, Qelbree reduced ADHD symptom scores as early as week 1.

Your child’s doctor can recommend Qelbree as part of a total treatment program that may include counseling and support therapies.

Clinical Trial Results

How we ran the studies:
Qelbree was studied in three clinical trials involving boys and girls ages 6-17 who had been diagnosed with ADHD.

The studies measured what kind of changes in ADHD symptoms these children experienced over the course of the six- to eight-week clinical trials. They measured the frequency and severity of ADHD symptoms, including inattention, hyperactivity, and impulsivity.

Qelbree showed significant reduction in symptoms compared to placebo.

Qelbree was also consistently proven to be effective and safe in multiple clinical studies in over 800 patients with a once-a-day convenient dose.

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Proven results

Safety profile

Qelbree is proven to be safe*, with manageable side effects

In clinical trials, Qelbree was consistently proven to be a safe and effective treatment for ADHD, with a low incidence of side effects.

*Important: Monitor your child for mood or behavior changes. Your child’s doctor may also monitor for changes in blood pressure and heart rate.

The majority of these side effects did not cause children to stop treatment with Qelbree.

Qelbree is not a controlled substance and there was no evidence of abuse.

Sometimes parents consider a planned break or "drug holiday" from a medication due to side effects. This is a conversation you should have with your child and with their doctor before considering a break.

Qelbree is unlikely to have any negative interactions with stimulants like methylphenidate and amphetamine.

Most Common Side Effects

Side effect

Placebo

Qelbree

Somnolence (drowsiness)^‡

16%

Decreased appetite

0.4%

Tiredness

Nausea

Vomiting

Irritability

Trouble sleeping^§

^‡Somnolence: somnolence, lethargy, sedation

^§Trouble sleeping: initial insomnia, insomnia, middle insomnia, poor quality sleep, sleep disorder, terminal insomnia.

Only 3% of participants taking Qelbree discontinued the clinical trial due to side effects, while 1% of those taking the placebo discontinued the clinical trial.

Savings and Resources

Learn more about the resources available to you with Qelbree.

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IMPORTANT SAFETY INFORMATION ABOUT QELBREE

INDICATION

Qelbree^® (viloxazine extended-release capsules) is a prescription medicine used to treat ADHD in adults and children 6 years and older.

IMPORTANT SAFETY INFORMATION
Qelbree may increase suicidal thoughts and actions, in children and adults with ADHD, especially within the first few months of treatment [read more] or when the dose is changed. Tell your doctor if you or your child have (or if there is a family history of) suicidal thoughts or actions before starting Qelbree. Monitor your or your child’s moods, behaviors, thoughts, and feelings during treatment with Qelbree. Report any new or sudden changes in these symptoms right away.

IMPORTANT SAFETY INFORMATION
Qelbree may increase suicidal thoughts and actions, in children and adults with ADHD, especially within the first few months of treatment or when the dose is changed. [read more] Tell your doctor if you or your child have (or if there is a family history of) suicidal thoughts or actions before starting Qelbree. Monitor your or your child’s moods, behaviors, thoughts, and feelings during treatment with Qelbree. Report any new or sudden changes in these symptoms right away.

You should not take Qelbree if you or your child:
Take a medicine for depression called a monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI in the past 14 days. Also, you or your child should avoid alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, and theophylline.

Qelbree can increase blood pressure and heart rate. Your or your child’s doctor will monitor these vital signs.

Qelbree may cause manic episodes in patients with bipolar disorder. Tell your doctor if you or your child show any signs of mania.

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

The most common side effects of Qelbree in patients 6 to 17 years are sleepiness, not feeling hungry, feeling tired, nausea, vomiting, trouble sleeping, and irritability, and in adults, insomnia, headache, sleepiness, tiredness, nausea, decreased appetite, dry mouth, and constipation. These are not all the possible side effects of Qelbree.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Medication Guide including Boxed Warning.