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How does Qelbree interact with
serotonin 5-HT2C
in the brain?1

Qelbree is the first and only ADHD non-stimulant with a multimodal pharmacodynamic profile1-4

Qelbree

  •  NET inhibition1*
    Qelbree binds to and inhibits NET (norepinephrine transporters)1
  •  Serotonin 5-HT2C partial agonist1
    Qelbree is the only ADHD treatment with serotonin pharmacodynamics approved in FDA product labeling1,5
  •  Qelbree is not a
    controlled substance1

Atomoxetine

  • NET inhibition4*

Psychostimulants

  • NET inhibition6,7*

  • DAT inhibition6,7

Psychostimulants impact DAT in the areas of the brain associated with addiction and are controlled substances.8,9

*Inhibition of NET increases NE levels in the PFC (prefrontal cortex)8

The pharmacodynamic activity of viloxazine is based on non-clinical studies and the clinical significance of the data is unknown. The mechanism of action of viloxazine in the treatment of ADHD is unclear; however, it is thought to be through inhibiting the reuptake of norepinephrine.1

Abbreviations: 5-HT2C, 5-hydroxytryptamine (serotonin) receptor 2C; DAT, dopamine transporter; NE, norepinephrine; PFC, prefrontal cortex.

 

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Mechanism of Delivery 

IMPORTANT SAFETY INFORMATION

INDICATION

Qelbree is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adult 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. Intuniv [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A.
  • 3. Kapvay [package insert]. Atlanta, GA: Shionogi Pharma, Inc.
  • 4. Strattera [package insert]. Indianapolis, IN: Lilly USA, LLC.
  • 5. Arnsten AFT. The emerging neurobiology of attention deficit hyperactivity disorder: the key role of the prefrontal association cortex. J Pediatr. 2009;154(5):I-S43. doi:10.1016/ j.jpeds.2009.01.018.
  • 6. Ritalin [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation.
  • 7. Adderall XR [prescribing information]. Horsham, PA. Teva Pharmaceuticals USA.
  • 8. Stahl SM. Stahl’s Essential Psychopharmacology: Neuroscientific Basis and Practical Applications. 5th ed. Cambridge University Press; 2021.
  • 9. Martin D, Le JK. Amphetamine. In: StatPearls. StatPearls Publishing; 2023. Accessed January 15, 2025. https://www.ncbi.nlm.nih.gov/books/NBK556103/

IMPORTANT SAFETY INFORMATION

INDICATION

Qelbree is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adult 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.