The approval of medicines called second-generation antipsychotics has allowed major depressive disorder (MDD) and other conditions linked to it to be treated. A person with MDD is usually prescribed an antidepressant to help treat symptoms, but sometimes they may still have unresolved depression symptoms. Sometimes, a health care provider may prescribe medicines to take with the antidepressant to make it work better. Vraylar (VRAY-lar) was approved in 2015 as an add-on medicine to antidepressant medicines.
How Does It Work for Major Depressive Disorder?
Major depressive disorder, also known as major depression, is a mental health condition that has a variety of symptoms, including sadness, fatigue, feeling worthless, and having little interest in activities, trouble sleeping, changes in appetite, and suicidal thoughts. The active ingredient in Vraylar is cariprazine. For some people, an antidepressant alone may not be enough to treat depression symptoms. Vraylar can be prescribed by your health care provider to take with an antidepressant that could improve your depression symptoms when compared to an antidepressant alone.
Vraylar is a second-generation antipsychotic, which is a class of medicines used to treat psychiatric conditions. Second-generation antipsychotics are different from first-generation antipsychotics because they are less likely to produce movement-related side effects (extrapyramidal symptoms) such as restlessness and tremor.
The exact way that Vraylar works is not known, but the medicine is designed to alter chemicals (serotonin and dopamine) in the brain that affect mood.
How Do I Take It?
Vraylar comes as 1.5-milligram, 3-milligram, 4.5-milligram, and 6-milligram capsules that you take by mouth once daily, with or without food. Take Vraylar as prescribed by your health care provider.
Vraylar in 1.5 milligrams will usually be prescribed on your first day of treatment with it. Your health care provider may increase the dose to 3 milligrams around the 15th day of treatment, depending on how well the dose is working and if you are tolerating the medicine. Three milligrams daily is the maximum dose you can take when you are taking Vraylar for MDD.
How Was It Studied for Major Depressive Disorder?
Two clinical studies were done in people with MDD to see if Vraylar was safe and effective.
In the first study, people received Vraylar (at a dose of 1.5 milligrams a day or 3 milligrams a day) or a placebo for 6 weeks. In the second study, people received either Vraylar or a placebo for 8 weeks. Those who received Vraylar were divided into two dosing groups: 1-2 milligrams or 2-4.5 milligrams. People in both studies were still taking their antidepressants as scheduled while in the study. The most common antidepressants that people were taking in the study were citalopram, duloxetine, escitalopram, sertraline, and venlafaxine.
People in both studies were between 18 and 65 years of age, with the average age being 45 years old. The studies included White Americans, African Americans, Asian Americans, or a category called “Other,” where race wasn’t specified. About 85% of the people in the study were White Americans, and about 72% of the people studied were women.
People in the studies had to meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5 or DSM-IV-TR) criteria, which are criteria that diagnose depression. They were in a depressive episode that was 8-24 weeks long and were on one to three antidepressant medicines that were not giving them full improvement in depression symptoms. The studies looked at changes in the Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline to week 6 (first study) or week 8 (second study). The MADRS looks at the degree of depressive symptoms based on a 10-point scale. The higher the score, the more severe the depression symptoms.
Across both studies, Vraylar was effective regardless of age, sex, or race. Your results may differ from what was seen in clinical studies.
What Benefits Were Seen?
In the first study, Vraylar lowered the MADRS score more than the placebo, with 1.5 milligrams of Vraylar showing the greatest score reduction. In the second study, Vraylar lowered the MADRS more than the placebo, with the dose range group of 2-4.5 showing the greatest score reduction.
Vraylar showed a greater reduction in the MADRS score, compared to placebo, meaning that people taking it had improved depression symptoms when compared to a placebo.
Your results may differ from what was seen in the clinical studies.
How Long Does It Take for Vraylar to Work?
Vraylar will start to work gradually, so it is important to take it every day and to not stop taking the medicine unless told by your health care provider. Because of this, it may take some time to see your symptoms improve, including improvement in your mood. Depending on your symptoms, your health care provider may decide to increase your dose, add medicines, or switch you to a different medicine.
During the first few months of starting Vraylar and after having your dose changed, the risk of suicidal thoughts and actions increases. If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your health care provider right away if you have any of the following symptoms.
- New or increased thoughts of suicide or death
- Suicide attempt
- New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior
How Can I Manage Side Effects?
The most common side effects seen in people with MDD treated with Vraylar are listed below.
- A movement disorder that makes it hard for you to sit still (akathisia)
- Restlessness
- Tiredness
- Constipation
- Nausea
- Trouble sleeping
- Increased appetite
- Dizziness
- Involuntary movements that you cannot control (extrapyramidal symptoms), including shakiness, stiffness, or jerkiness
Vraylar stays in your body for a long time. Some side effects may not happen right away and may happen after a few weeks, especially if your Vraylar dose has increased.
Talk to your health care provider if you have extrapyramidal symptoms, akathisia, or if you’re feeling restless due to Vraylar. Your health care provider may lower the dose of your medicine, prescribe you medicine to treat your symptoms, or switch you to another medicine.
If you are having nausea, there are things you can do to try to manage it. Drink plenty of water to avoid becoming dehydrated; eat more bland foods such as bread, toast, and bananas; eat smaller but more frequent meals; and avoid strong smells. If your nausea symptoms have not gone away or are getting worse, call your health care provider.
Constipation can happen as a result of taking Vraylar. If you get constipated, drinking plenty of water, eating fiber (as a supplement or from food), and exercising regularly can help manage your symptoms. Avoiding high-fat foods such as meats and cheeses may help. Talk to your health care provider if you can’t have a bowel movement. Your health care provider may recommend over-the-counter medicines that can help, which can include stool softeners, fiber supplements, or laxatives. Tell your health care provider about all the medicines that you take. Certain medicines can cause constipation, and if taken with Vraylar, they may make constipation worse. Foods with higher fiber content are listed below.
- Fruits
- Vegetables
- Beans
- Brown rice
- Bran cereal
You may get tired or dizzy while taking Vraylar. It is important not to drive or do other activities that require alertness or coordination until you know how Vraylar affects you.
Vraylar may cause trouble sleeping, also known as insomnia. Talk to your health care provider if you are having problems falling asleep or staying asleep while on Vraylar.
Your appetite may increase and cause you to get hungrier while you are taking Vraylar, which may cause you to gain weight. Exercising regularly and eating a well-balanced diet may help. Talk to your health care provider about potential weight gain while on Vraylar. They may monitor your weight and may also monitor your sugar and cholesterol levels while you’re on Vraylar.
What Type of Drug Interactions Can Happen?
Other medicines may alter the blood levels of Vraylar. This may increase the risk of side effects from Vraylar or can cause Vraylar to not work as well. Talk to your health care provider about all the prescription medicines, over-the-counter medicines, and supplements that you are taking. They will decide if they will need to modify any of the medicines that you are taking or modify your Vraylar dose.
Is There a Cost Savings Program?
There is a savings card available from the drugmaker that may allow you to pay $0 for your first two 30-day supply prescriptions or $5 per 30-day refill or 90-day refill. Whether you are eligible depends on your insurance coverage. You can find out more at https://www.vraylar.com/cost-and-savings or by calling 800-678-1605.
