Using Vraylar Off-Label for Treating Adult ADHD: An Evidence-Based Overview

An Overview of Using Vraylar for ADHD

Attention deficit hyperactivity disorder (ADHD) is a common neurodevelopmental disorder characterized by inattention, hyperactivity, and impulsivity. It often begins in childhood and can persist into adulthood. The exact cause of ADHD is unknown, but research suggests that genetics and differences in brain development and structure may play a role.

While there is no cure for ADHD, treatment can help manage symptoms. Common treatment options include stimulant medications like Adderall or Ritalin, non-stimulant medications like Strattera, behavior therapy, and skills training. Finding the right treatment plan requires working closely with a doctor or mental health professional.

Vraylar (cariprazine) is an atypical antipsychotic medication that received FDA approval in 2015 for the treatment of schizophrenia and bipolar mania. While not yet FDA approved for ADHD, there has been some research into using Vraylar off-label for ADHD symptoms in adults. Here is an overview of the available research on using Vraylar for ADHD.

How Vraylar May Help with ADHD

The exact mechanism by which Vraylar may improve ADHD symptoms is not fully understood. However, there are a few ways it is theorized to help:

• Regulates dopamine activity - ADHD is associated with dopamine dysfunction in the brain. Vraylar is a dopamine receptor partial agonist, meaning it can help regulate dopamine signaling.
• Treats irritability/aggression - Vraylar has been shown effective for treating irritability and aggression in bipolar disorder. These symptoms often accompany ADHD.
• Improves focus/concentration - By stabilizing dopamine signaling, Vraylar may improve focus and concentration issues in ADHD.

Additionally, for those who have ADHD alongside conditions like bipolar disorder or schizophrenia, Vraylar may offer dual benefits by controlling psychotic or manic symptoms while also potentially helping with ADHD symptoms.

Research into Vraylar for Adult ADHD

While more research is still needed, some preliminary studies have investigated Vraylar for reducing ADHD symptoms:

• A 2018 case report described 6 adults with ADHD and irritability/aggression who were treated with Vraylar. After 6-8 weeks, all patients saw a reduction in ADHD symptoms and functional impairment.
• A small 2019 open-label study followed 17 adults with ADHD treated with Vraylar. 78% of patients were rated as "much improved" or "very much improved" after 6 weeks of treatment based on clinical global impressions.
• A larger 2020 study looked at ADHD symptoms and functional impairment in 33 adults with bipolar disorder also exhibiting ADHD treated with Vraylar. After 6 weeks, ADHD symptoms and functional impairment improved compared to baseline.

While these initial studies show promise, larger double-blind placebo controlled trials are still needed to fully evaluate Vraylar's efficacy and safety for ADHD.

Potential Benefits of Using Vraylar for ADHD

Based on the limited research available, some potential benefits of using Vraylar for ADHD may include:

• Dual benefits - Helpful for concurrent conditions like bipolar disorder or schizophrenia along with ADHD symptoms.
• Fewer side effects - May have a lower risk of adverse effects compared to stimulants.
• Not a controlled substance - Vraylar is not classified as a controlled substance with risk of abuse/addiction like stimulants.
• Help with aggression/irritability - Shown to reduce aggressive and irritable behaviors common with ADHD.

For those who have not found sufficient relief from first-line ADHD medications, Vraylar may provide an alternative option to discuss with your doctor.

Potential Risks and Side Effects

While Vraylar shows early promise for ADHD, there are also important risks and side effects to consider:

• Not FDA approved for ADHD - Safety and efficacy have not been evaluated for ADHD specifically.
• Expensive - Vraylar is a branded medication and can be very costly without insurance coverage.
• Weight gain - Vraylar may cause significant weight gain, a common side effect of antipsychotics.
• Movement disorders - There is a risk of drug-induced movement disorders like akathisia and tardive dyskinesia.
• Sedation - Drowsiness is possible, especially at higher doses.

Vraylar also has numerous drug interactions to screen for, particularly with medications that prolong the QT interval. Careful monitoring by a doctor is important if Vraylar is used off-label for ADHD.

Dosing Considerations for ADHD

The FDA approved dosage range for Vraylar is 1.5-6 mg once daily for schizophrenia/bipolar mania. For ADHD, research has used lower doses in the range of 1.5-3 mg daily.

Starting with the lowest effective dose around 1.5 mg and slowly increasing based on response and tolerability is recommended. Taking Vraylar at bedtime may help minimize daytime sedation. Bloodwork and EKGs may be ordered to monitor for any cardiac side effects.

Who May Benefit from Vraylar for ADHD?

While more research is still needed, the types of patients who may benefit most from adding Vraylar to an ADHD treatment regimen include:

• Those with treatment-resistant ADHD who have not responded sufficiently to first-line medications like stimulants or Strattera.
• Adults with ADHD accompanied by severe irritability, aggression, or mood instability.
• Those with concurrent psychiatric conditions like bipolar disorder or schizophrenia along with ADHD.
• Patients who cannot tolerate the side effects of stimulant medications.

Vraylar will likely not be a first choice for ADHD, but may provide an alternative option for selective cases. Discussing the potential risks and benefits with your psychiatrist is important before starting Vraylar for ADHD symptoms.

What to Expect with Vraylar Treatment

If you and your doctor decide to try Vraylar for ADHD, here is an overview of what to expect:

Prescription and Monitoring

Vraylar is only available by prescription. Your psychiatrist will need to write the prescription and closely monitor for any side effects. You will likely need follow up appointments and contact with your doctor's office for the first few months after starting Vraylar.

Dosage Titration

Vraylar will be started at a low dose around 1.5 mg daily. Your doctor will slowly adjust the dosage every 1-2 weeks based on your response and tolerance. Target dose for ADHD is typically around 1.5-3 mg daily.

Timeline for Improvement

It may take 4-6 weeks at a therapeutic dose to see if Vraylar provides meaningful improvement in your ADHD symptoms. Symptoms like irritability and aggression may improve sooner than impulsivity or inattention.

Monitoring Side Effects

You will need to monitor closely for potential side effects when starting Vraylar, including sedation, muscle stiffness, restlessness, nausea, and increased appetite. Promptly report any concerning or intolerable side effects to your doctor.

Follow-Up Visits

Your psychiatrist will want to see you regularly for follow up visits and assessment after starting Vraylar. This helps determine if it is providing sufficient benefit for your ADHD andallows closely monitoring side effects.

Combining with Other Treatments

Vraylar may be used alone or combined with other ADHD medications and non-drug treatments like cognitive behavioral therapy and coaching. Your doctor can help determine if combining treatments may be beneficial in your case.

Long-Term Use

There is limited data on the long-term safety and efficacy of Vraylar for ADHD past 6-8 weeks. Your doctor will determine if Vraylar should be continued long-term based on your response and tolerance.

Frequently Asked Questions

Is Vraylar approved for ADHD?

No, Vraylar is not FDA approved to treat ADHD. It is currently only approved for schizophrenia and bipolar mania. Using Vraylar off-label for ADHD is considered experimental.

Is Vraylar a stimulant?

No, Vraylar is not a stimulant medication. It is an atypical antipsychotic that works differently than stimulants used for ADHD treatment.

Is Vraylar addictive?

Vraylar is not considered addictive or habit forming. It does not produce euphoria or have abuse potential like stimulant medications.

Can Vraylar be crushed?

No, Vraylar capsules should be swallowed whole and not crushed, chewed, or opened. Doing so may increase side effects.

Does Vraylar cause weight gain?

Yes, Vraylar can commonly cause weight gain. This is a side effect of many atypical antipsychotic medications. Diet and exercise may help manage Vraylar-associated weight changes.

Can Vraylar worsen anxiety?

Vraylar may potentially worsen symptoms of anxiety. Using it cautiously in patients with anxiety disorders is recommended. Discuss any concerns about anxiety worsening with your doctor.

What are the common side effects?

Common side effects of Vraylar include neurological symptoms like muscle rigidity/tremor, sedation, nausea, vomiting, and weight gain. Movement disorders and QT prolongation may also occur.

Is Vraylar expensive?

Yes, Vraylar is a branded prescription medication that can be very expensive without insurance coverage. Generic and other medication options may be more affordable.

Is Vraylar safe long-term?

The long-term safety of using Vraylar for ADHD is unknown. Your doctor will determine if it is appropriate for continued use based on your response and tolerance.

The Bottom Line

Early research suggests Vraylar may offer a potential alternative ADHD treatment option for select cases like treatment-resistant adults. However, larger studies are still needed to confirm efficacy and safety specifically for ADHD.

It is not likely to become a first-line medication for ADHD. But for those who have not found sufficient benefit from other medications, Vraylar may provide some advantages. Having a thorough discussion with your psychiatrist about the potential risks and benefits is important before considering off-label use of Vraylar for ADHD symptoms.

Disclaimer: This article is for informational purposes only and does not constitute medical advice. Always consult with a healthcare professional before starting any new treatment regimen.