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Proven safety and tolerability across multiple Phase III clinical trials1

Qelbree safety profile for children, teens, and adults with ADHD (6 years and older).

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Actor portrayals.
A woman and her two daughters stand outside, smiling.

Once-daily Qelbree shows no evidence of abuse potential in all pediatric and adult studies—minimizing risk of treatment abuse, misuse, or diversion.1-3



Qelbree has a well-characterized safety profile1

 

Adverse reactions for children and teens with ADHD in clinical studies

A table outlines the most common adverse events for Children/Teens 6-17 years of age, reported in Phase III trials, comparing the placebo group (n=463) to the Qelbree group (n=826). The reported rates for placebo versus Qelbree are 4% vs 16% for Somnolence, 0.4% vs 7% for Decreased appetite, 2% vs 6% for Fatigue, 3% vs 5% for Nausea, and 2% vs 4% for Vomiting.

*The following items were combined:

  • Somnolence: Somnolence, lethargy, sedation
  • Insomnia: Initial insomnia, insomnia, middle insomnia, poor quality sleep, sleep disorder,  terminal insomnia
    Low AE discontinuation rates in pediatric trials: a 1% adverse event discontinuation rate for placebo and a 3% adverse event discontinuation rate for Qelbree.

     

    Adverse reactions for adults with ADHD in clinical study

    A table outlines the most common adverse events for Adults (18-65 Years) reported in an adult Phase III trial, comparing the placebo group (n=183) to the Qelbree group (n=189). The specific reported rates for placebo versus Qelbree are 7% vs 23% for Insomnia, 7% vs 17% for Headache, 3% vs 12% for Fatigue, 3% vs 12% for Nausea, 3% vs 10% for Decreased appetite, 2% vs 10% for Dry mouth, 2% vs 6% for Somnolence, and 1% vs 6% for Constipation.

    †The following items were combined:

    • Somnolence: Somnolence, lethargy, sedation
    • Headache: Headache, migraine, migraine with aura, tension headache
    • Insomnia: Initial insomnia, insomnia, middle insomnia, poor quality sleep, sleep disorder, terminal insomnia
    AE discontinuation rates in adult trial: 5% adverse event discontinuation rate for placebo and a 9% adverse event discontinuation rate for Qelbree.

     

    Additional Qelbree safety information

    Cardiac Safety: Treatment did not appear to have any influence on ECG changes1

    Stimulant Compatibility: Unlikely to have DDIs with amphetamines or methylphenidate1

    Hepatic Profile: No clinically relevant liver enzyme elevation1

    No Evidence of Abuse Potential: Studies showed no evidence of abuse1-3

    SSRI Compatibility: No contraindications with SSRIs1

    CONTRAINDICATIONS

    • Concomitant administration of a monoamine oxidase inhibitor (MAOI), or dosing within 14 days after discontinuing an MAOI, because of an increased risk of hypertensive crisis
    • Concomitant administration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range

    Abbreviations: ADHD, attention-deficit/hyperactivity disorder; AE, adverse event; DDI, drug-drug interaction; ECG, electrocardiogram; SSRI, selective serotonin reuptake inhibitor.

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    IMPORTANT SAFETY INFORMATION

    INDICATION

    Qelbree (viloxazine extended-release capsules) is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.

    IMPORTANT SAFETY INFORMATION

    WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

    In clinical studies, higher rates of suicidal thoughts and behaviors were reported in [read more] patients with ADHD treated with Qelbree than in patients treated with placebo. Closely monitor all Qelbree-treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors.

    In clinical studies, higher rates of suicidal thoughts and behaviors were reported in patients with ADHD treated with Qelbree than in patients treated with placebo. Closely monitor all [read more] Qelbree-treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors.

    CONTRAINDICATIONS

    • Concomitant administration of a monoamine oxidase inhibitor (MAOI), or dosing within 14 days after discontinuing an MAOI, because of an increased risk of hypertensive crisis
    • Concomitant administration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range

    WARNINGS & PRECAUTIONS

    • Suicidal thoughts and behaviors: Closely monitor all Qelbree-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes
    • Heart rate, blood pressure increases: Qelbree can cause an increase in diastolic blood pressure and heart rate. Assess these measures prior to starting therapy, following increases in dosage, and periodically during therapy
    • Activation of mania or hypomania: Noradrenergic drugs may induce a manic or mixed episode in patients with bipolar disorder. Prior to initiating treatment with Qelbree, screen patients to determine if they are at risk for bipolar disorder. Screening should include a detailed psychiatric history, including a personal or family history of suicide, bipolar disorder, and depression 
    • Somnolence and fatigue: Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, due to potential somnolence (including sedation or lethargy) and fatigue, until they know how they will be affected by Qelbree 

    ADVERSE REACTIONS

    The most common adverse reactions (≥ 5% and at least twice the rate of placebo for any dose) in patients 6 to 17 years were somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability, and in adults, insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth, and constipation. 

    PREGNANCY

    There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Qelbree during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or by visiting www.womensmentalhealth.org/preg. 

    Please see full Prescribing Information, including Boxed Warning.

    References:

    1. Qelbree [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.
    2. Key prescription stimulant label updates. U.S. Food and Drug Administration. May 11, 2023. Accessed June 25, 2026. https://www.fda.gov/media/168050/download
    3. Yanagita T, Wakasa Y, Kiyohara H. Drug dependence potential of viloxazine hydrochloride tested in rhesus monkeys. Pharmacol Biochem Behav. 1980;12(1):155-161. doi:10.1016/0091-3057(80)90430-x
    4. Data on file, Supernus Pharmaceuticals, Inc.

    IMPORTANT SAFETY INFORMATION

    INDICATION

    Qelbree (viloxazine extended-release capsules) is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.

    IMPORTANT SAFETY INFORMATION

    WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

    In clinical studies, higher rates of suicidal thoughts and behaviors were reported in [read more] patients with ADHD treated with Qelbree than in patients treated with placebo. Closely monitor all Qelbree-treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors.

    In clinical studies, higher rates of suicidal thoughts and behaviors were reported in patients with ADHD treated with Qelbree than in patients treated with placebo. Closely monitor all [read more] Qelbree-treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors.

    CONTRAINDICATIONS

    • Concomitant administration of a monoamine oxidase inhibitor (MAOI), or dosing within 14 days after discontinuing an MAOI, because of an increased risk of hypertensive crisis
    • Concomitant administration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range

    WARNINGS & PRECAUTIONS

    • Suicidal thoughts and behaviors: Closely monitor all Qelbree-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes
    • Heart rate, blood pressure increases: Qelbree can cause an increase in diastolic blood pressure and heart rate. Assess these measures prior to starting therapy, following increases in dosage, and periodically during therapy
    • Activation of mania or hypomania: Noradrenergic drugs may induce a manic or mixed episode in patients with bipolar disorder. Prior to initiating treatment with Qelbree, screen patients to determine if they are at risk for bipolar disorder. Screening should include a detailed psychiatric history, including a personal or family history of suicide, bipolar disorder, and depression 
    • Somnolence and fatigue: Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, due to potential somnolence (including sedation or lethargy) and fatigue, until they know how they will be affected by Qelbree 

    ADVERSE REACTIONS

    The most common adverse reactions (≥ 5% and at least twice the rate of placebo for any dose) in patients 6 to 17 years were somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability, and in adults, insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth, and constipation. 

    PREGNANCY

    There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Qelbree during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or by visiting www.womensmentalhealth.org/preg. 

    Please see full Prescribing Information, including Boxed Warning.