Yes, sleepiness or drowsiness can be a common side effect with Vraylar in about 6% to 7% of patients compared to 4% receiving a placebo (inactive) medicine.

Vraylar (cariprazine) is an oral, once daily atypical antipsychotic medicine used to treat schizophrenia, bipolar mania, bipolar depression and major depressive disorder (as an add-on medicine to antidepressant therapy) in adults.

• In clinical studies of Vraylar in patients with bipolar mania, somnolence (drowsiness or sedation) was reported in 7% to 8% of Vraylar-treated patients compared to 4% of patients taking an inactive placebo.
• In clinical studies in patients being treated for schizophrenia, somnolence or sedation was reported in 5% to 10% of patients receiving Vraylar, and in 5% of those taking an inactive placebo. Drowsiness appears to occur more frequently with higher doses of Vraylar in patients with schizophrenia.
• In patients being treated with Vraylar for bipolar depression, 6% to 7% of patients reported somnolence compared to 4% of those taking a placebo.

Side effects with medications can vary between patients. Your side effects may be the same or different from other patients also taking Vraylar.

Use caution if Vraylar makes you sleepy

Do not drive, operate machinery, or do other dangerous activities until you know how you will react to Vraylar. Vraylar may also increase your risk for a fall, bone fracture or other injury, especially if you are drowsy or sedated. These effects may be especially common in older patients. Avoid drinking alcohol while taking Vraylar. Dangerous side effects could occur.

Vraylar stays in your body for a long time. Vraylar and its active metabolites have a long half-life up to three weeks. Some side effects may not occur until a few weeks after starting Vraylar or after a dose change.

Common side effects associated with Vraylar include:

• sleepiness
• restlessness
• difficulty moving or slow movements
• tremors
• uncontrolled body movements (extrapyramidal symptoms or EPS)
• feeling like you need to move around (akathisia)
• nausea
• vomiting
• indigestion.

Your health care provider will monitor you for side effects after starting or adjusting your dose of Vraylar. If your doctor should stop your Vraylar treatment, it may take several weeks or longer for any side effects to go away. Do not stop taking Vraylar unless your doctor has recommended that you stop treatment.

These are not all the possible side effects that can occur with Vraylar. Call your doctor for medical advice about side effects.

Learn More: Side Effects with Vraylar (in more detail)

Bottom Line

• Drowsiness or sleepiness is a common side effect with Vraylar (cariprazine). In general, roughly 6% to 7% (6 or 7 out of every 100) of patients may experience drowsiness as a side effect with Vraylar.
• Sleepiness due to Vraylar can increase your risk for an injury. Do not drive, operate machinery, or do other dangerous activities until you know how you will react to Vraylar.
• Always speak to your doctor for medical advice if you have side effects that concern you or won't go away.

This is not all the information you need to know about Vraylar (cariprazine) for safe and effective use. Review the full Vraylar product information here, and discuss this information with your doctor or other health care provider.