Qelbree: A Guide for Patients with ADHD

Understanding Qelbree for ADHD Treatment:

Non-stimulant medications play a crucial role in the treatment of ADHD, particularly for patients who may not respond well to or tolerate stimulant medications. Qelbree, a relatively new addition to the non-stimulant category, offers a promising alternative with its FDA approval for both children and adults. Supported by robust clinical trials, Qelbree has demonstrated significant improvements in ADHD symptoms, making it a valuable option in the diverse arsenal of ADHD treatment. 

Efficacy: Clinical trials and studies have shown that Qelbree (viloxazine) significantly improves symptoms of ADHD in both children and adults. In a pivotal Phase III study, adults showed an average symptom reduction of 18.2 points on the Adult ADHD Investigator Symptom Rating Scale after treatment with Qelbree.

Dosing Information:

  • Children (6-11 years): Start with 100 mg daily, increasing weekly to a maximum of 400 mg.

  • Adolescents (12-17 years): Start with 200 mg daily, increasing weekly to a maximum of 400 mg.

  • Adults (18+ years): Start with 200 mg daily, increasing weekly to a maximum of 600 mg.

When to Take Qelbree: Qelbree should be taken once daily, with or without food. The capsules should be swallowed whole or can be opened and sprinkled onto a teaspoonful of applesauce and consumed immediately without chewing.

Potential Side Effects: Common side effects of Qelbree include sleepiness, tiredness, decreased appetite, nausea, and irritability. More serious side effects can include increased blood pressure and heart rate, manic episodes, and an increased risk of suicidal thoughts and actions, particularly during the first few months of treatment or when the dose is changed.

Potential Contraindications: Qelbree should not be taken by patients who are taking or have recently taken monoamine oxidase inhibitors (MAOIs), as it increases the risk for serotonin syndrome. It is also advised to avoid Qelbree in patients with a known hypersensitivity to viloxazine. 

FDA Approval Information: Qelbree was approved by the U.S. Food and Drug Administration (FDA) for the treatment of ADHD in adults and children aged 6 to 17 years in April 2021. This approval was based on the results from controlled clinical trials that demonstrated its efficacy and safety.

Off-Label Benefits Backed by Research: While primarily approved for the treatment of ADHD, ongoing research may reveal additional benefits of Qelbree in other areas of mental health, though these uses would be considered off-label until further FDA approvals are granted.

Sources:

  1. Additude: https://www.additudemag.com/medication/qelbree/

  2. American Academy of Family Physicians: https://www.aafp.org/pubs/afp/issues/2023/0300/steps-viloxazine-adhd.html

  3. Qelbree Medication Guide: https://www.qelbree.com/quelbree-medication-guide.pdf

  4. National Alliance on Mental Illness: https://www.nami.org/about-mental-illness/treatments/mental-health-medications/types-of-medication/viloxazine-qelbree/

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