What if there were a treatment that could potentially help the management of Attention-Deficit/Hyperactivity Disorder (ADHD) for countless individuals? Viloxazine (Qelbree), an FDA-approved non-stimulant medication for the treatment of ADHD, may be the answer.
Originally developed as an antidepressant in the 1970s, viloxazine was later withdrawn from the market for that use. However, researchers discovered that it had unique effects on brain chemicals linked to ADHD, leading to its approval as a non-stimulant ADHD medication.
Today, viloxazine offers a new option for patients who cannot tolerate or prefer to avoid stimulant medications. This article explores how viloxazine works, its benefits, potential risks, and its role in ADHD treatment, helping patients and providers make informed decisions.
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Understanding Viloxazine
Attention-Deficit/Hyperactivity Disorder (ADHD) affects millions of people worldwide, making daily tasks and focus challenging. While stimulant medications are commonly used, some patients benefit from non-stimulant treatments like viloxazine.
What Is Viloxazine?
Viloxazine (Qelbree) is a non-stimulant medication used to treat ADHD. It was originally developed as an antidepressant in Europe in the 1970s but was later discontinued for that purpose. Researchers later discovered its potential in managing ADHD symptoms, leading to its approval.
- Chemical Classification: Viloxazine is a selective norepinephrine reuptake inhibitor (SNRI), meaning it helps regulate certain brain chemicals linked to focus and impulse control.
- Non-Stimulant Nature: Unlike some other ADHD medications, viloxazine does not contain amphetamines. This makes it a safer option for individuals who cannot tolerate stimulants. Unlike stimulants, viloxazine has a lower risk of addiction and abuse.
Viloxazine’s FDA Approval
Viloxazine received FDA approval in 2021 for ADHD treatment in pediatric patients aged 6-17. A year later, in 2022, the approval expanded to include adults with ADHD, making viloxazine one of the few non-stimulant options available for adult patients.
FDA approval was based on multiple clinical trials that evaluated viloxazine’s effectiveness and safety that showed:
- Improvements in ADHD symptoms, including attention, hyperactivity, and impulse control.
- Participants who received viloxazine showed improvement as early as two to four weeks after starting the medication.
- Viloxazine was well tolerated, with low discontinuation rates due to side effects.
Mechanism of Action
ADHD is linked to imbalances in brain chemicals called neurotransmitters, which control attention, behavior, and emotions. Viloxazine modulates these neurotransmitters.
How Viloxazine Works
Viloxazine mainly affects norepinephrine and serotonin, two neurotransmitters that help with mood regulation and focus. Unlike stimulant medications, which target dopamine, viloxazine works more gradually and has a lower risk of dependence.
Targeted Effects on the Brain
Viloxazine blocks norepinephrine reuptake, meaning it increases norepinephrine levels in the brain. This helps with:
- Attention and focus
- Impulse control
- Emotional (mood) stability
Additionally, viloxazine interacts with serotonin receptors, which may help improve mood and reduce anxiety—a common issue in people with ADHD.
Clinical Applications
Viloxazine is FDA-approved for the treatment of ADHD. Clinical data suggests that it effectively improves attention, impulse control, and overall executive functioning in individuals diagnosed with ADHD.
Patient Demographics: Who Can Use Viloxazine?
- Children (6-11 years old): Approved for use with demonstrated benefits in reducing hyperactivity and improving focus.
- Adolescents (12-17 years old): Studies show sustained symptom improvement.
- Adults (18+ years old): FDA approval expanded based on clinical evidence of effectiveness in managing adult ADHD symptoms.
Who Might Benefit from Viloxazine?
People who are more likely to benefit from viloxazine over other types of ADHD medications include:
- Individuals who cannot tolerate stimulant medications due to side effects like insomnia, irritability, or increased heart rate.
- Patients with a history of substance use disorder, as viloxazine has a lower potential for misuse or addiction.
- Those with anxiety or mood disorders, as viloxazine’s serotonin activity may offer additional benefits.
Dosage and Administration
Viloxazine is an extended-release capsule taken once daily, with or without food. Capsules should not be crushed or chewed but may be opened and sprinkled on soft food such as applesauce.
Recommended Dosages
The typical dosages are:
- Children (6-11 years): 100 mg once daily, with a maximum of 400 mg/day as tolerated.
- Adolescents (12-17 years): 200 mg once daily, with a maximum of 400 mg/day.
- Adults (18+ years): 200 mg once daily, titrated up to 600 mg/day based on clinical response.
A healthcare provider should monitor treatment regularly, especially in the first few months, to assess effectiveness and tolerability. Dosage adjustments should be made only under medical supervision based on treatment response, tolerability, and clinical guidelines outlined in the FDA prescribing information.
Benefits and Risks
Clinical studies have shown viloxazine may improve ADHD symptoms in some patients. However, individual responses to treatment may vary.
Benefits of Viloxazine
Benefits of viloxazine include:
- Improved core ADHD symptoms (attention, impulsivity, and hyperactivity).
- Provides a non-stimulant option for people who cannot take stimulant medications.
- Once-daily dosing, which enhances convenience and medication compliance.
- Lower risk of dependence compared to stimulant medications.
- May provide additional mood-stabilizing effects, which can be beneficial for patients with coexisting anxiety or emotional dysregulation.
Potential Side Effects
Viloxazine has potential side effects, but not all patients will experience them. Most side effects are mild to moderate and tend to decrease over time.
Common Side Effects
- Drowsiness or fatigue
- Decreased appetite
- Nausea or vomiting
- Irritability
- Sleep disturbances (insomnia or excessive drowsiness)
Less Common, But Serious Side Effects
- Increased blood pressure (BP) and heart rate: Vital signs, including BP and heart rate, should be routinely monitored, particularly in patients with existing cardiovascular conditions.
- Mood changes: Some patients may experience mood swings, irritability, or, in rare cases, increased suicidal thoughts (as with many psychiatric medications).
- Liver enzyme elevation: Routine liver function tests may be recommended for patients with pre-existing liver conditions.
Other side effects not listed above may also occur. Report any new, persistent, or serious side effects to your healthcare provider.
Who Should Avoid Viloxazine?
Patients with heart conditions, liver disease, or those taking certain medications should undergo regular medical monitoring as recommended by their healthcare provider.
Contraindications and Precautions
- Liver and kidney disease: Those with severe liver or kidney disease should use viloxazine with caution, as it is metabolized in the liver.
- MAO inhibitors: People taking MAO inhibitors (e.g., isocarboxazid, phenelzine, selegiline, tranylcypromine) should avoid viloxazine due to potential drug interactions.
- Cardiovascular disease: People with uncontrolled hypertension or cardiovascular disease should consult their doctor before use.
- Pregnancy and breastfeeding: There is limited safety data on viloxazine use during pregnancy and breastfeeding. Pregnant or nursing individuals should discuss risks versus benefits with their healthcare provider.
Patients should inform their doctor about all medications they are taking, including antidepressants and blood pressure medications, to avoid interactions.
Comparing Viloxazine to Other Treatments
Choosing the right ADHD treatment depends on its effectiveness, side effects, and risks.
Stimulants vs. Non-Stimulants
Stimulants work fast and are very effective but may cause anxiety, sleep problems, or have a risk of misuse. Viloxazine, a non-stimulant, works differently by affecting norepinephrine and serotonin. It takes longer to work but has a lower risk of addiction and may help with mood and anxiety.
Here’s how viloxazine compares to stimulants:
Viloxazine offers an effective, non-stimulant alternative for ADHD treatment. While it may not work for everyone, it provides a valuable option for individuals who cannot take stimulants or prefer a non-addictive treatment approach. Patients should work with their healthcare provider to determine the best ADHD management strategy.
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Key Takeaways
- Viloxazine (Qelbree) is an FDA-approved non-stimulant medication for ADHD, available for children (6+), adolescents, and adults. It works differently from stimulant medications by targeting norepinephrine and serotonin rather than dopamine.
- Clinical studies show viloxazine may improve ADHD symptoms, including attention, impulse control, and hyperactivity. However, individual responses to treatment vary, and it may take weeks to show full effects.
- Viloxazine is not a controlled substance, meaning it has a lower potential for misuse than stimulant medications. However, its long-term effects on dependence are still being studied.
- Common side effects include drowsiness, decreased appetite, nausea, irritability, and sleep disturbances. More serious but rare side effects include increased blood pressure, mood changes, and liver enzyme elevation.
- Viloxazine may be a good option for individuals who cannot tolerate stimulants, especially those with a history of substance use disorder or co-occurring anxiety and mood disorders.
- Dosage varies by age group, starting at 100mg for children and 200mg for adolescents and adults, with adjustments based on tolerance and effectiveness. It should only be taken under medical supervision.
- Patients should consult their doctor before taking viloxazine, especially if they have heart conditions, liver disease, or are taking other medications.
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