Does caffeine affect Vraylar (cariprazine)?

Caffeine is not listed as having a drug interaction with the atypical antipsychotic medicine Vraylar (generic name: cariprazine). However, Vraylar may lead to restlessness, the feeling of the need to move around (akathisia), or trouble with sleeping (insomnia) in some patients. Call a health care provider right away if you or your family member has any of these symptoms while receiving Vraylar, especially if they are worrisome, a new or worsened side effect, or do not go away.

Enzymes found in the body can be responsible for breaking down (metabolizing) some drugs. Caffeine is metabolized by the CYP1A2 enzyme. However, according to the manufacturer, Vraylar is NOT a substrate for CYP1A2, does not induce CYP1A2 enzymes and is a weak inhibitor of CYP1A2. Based on in vitro studies, Vraylar is unlikely to cause clinically significant pharmacokinetic drug interactions with substrates of CYP1A2.

Learn more: Drug, food, alcohol and disease interactions with Vraylar (cariprazine)

What does Vraylar treat?

Vraylar is an oral, once daily atypical antipsychotic approved to treat schizophrenia, manic or mixed episodes of bipolar I disorder, depressive episodes associated with bipolar I disorder (bipolar depression), and as an adjunct treatment for major depressive disorder (with antidepressant therapy) in adults.

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. 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 because of a side effect, it may take weeks for the side effect to decline.

Restlessness is noted as a common side effect with Vraylar. Other common side effects include:

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

A common side effect occurs in at least 5% (5 out of every 100) patients and at least twice as often as those taking a placebo (inactive treatment).

See: Vraylar Side Effects (in more detail)

Does Vraylar cause insomnia?

Insomnia (trouble falling or staying asleep) has been reported as a side effect with Vraylar. However, insomnia appears to occur at about a similar rate as an inactive placebo, which suggests that this effect may not always be due to the medicine.

• For example, when used to treat schizophrenia, insomnia with Vraylar occurred in 11% to 13% of patients, and 11% of those receiving the placebo.
• When used to treat bipolar mania, insomnia with Vraylar occurred in 8% and 9% of patients, compared to 7% of those receiving the placebo.
• When used to treat bipolar depression, insomnia with Vraylar occurred in 7% and 10% of patients, and 7% of those receiving the placebo.

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Is insomnia a symptom of schizophrenia or bipolar disorder?

Insomnia, or trouble sleeping, can be associated with many mental health disorders, including schizophrenia, and bipolar disorder.

• If you take Vraylar and are having trouble with sleep, contact your doctor immediately for further advice. Lack of sleep may be a symptom of your condition being treated. Lack of sleep might also worsen the success of your treatment.
• If you find that you are having trouble sleeping after starting Vraylar, you may also want to cut back on any caffeine consumption, especially later in the day. This includes coffee, tea, cola, chocolate and energy drinks.

Does Vraylar cause restlessness?

Vraylar can lead to restlessness and is listed as a common side effect of Vraylar.

• In studies looking at treatment of patients with schizophrenia, restlessness with Vraylar occurred in 4% to 6% of patients, and 3% of those receiving the placebo.
• When used to treat bipolar mania, restlessness with Vraylar occurred in 7% of patients, and 2% of those receiving the placebo.
• When used to treat bipolar depression, restlessness with Vraylar occurred in 2% and 7% of patients, compared to 3% of those receiving the placebo.

Does Vraylar cause akathisia?

Akathisia, which is an inner feeling of restlessness and the inability to sit still, is also a common side effect of Vraylar. Patients may find this is a distressing side effect.

Your doctor should monitor you for akathisia for several weeks after you start Vraylar treatment or after you have a dose increase.

• In studies looking at treatment of patients with schizophrenia, akathisia with Vraylar occurred in 9%, 13% and 14% of patients, compared to 4% of those receiving the placebo. Higher rates of akathisia occurred with higher doses of Vraylar.
• When used to treat bipolar mania, akathisia with Vraylar occurred in 20% and 21% of patients, and 5% of those receiving the placebo. In bipolar mania studies, some patients stopped treatment with Vraylar due to the akathisia side effect.
• In bipolar depression studies, akathisia reported with Vraylar occurred in 6% and 10% of patients, compared to 2% of those receiving the placebo.

Bottom Line

• Caffeine has not been shown to have a drug interaction with the atypical antipsychotic medicine Vraylar (generic name: cariprazine).
• However, Vraylar may lead to restlessness, the feeling the need to move around (akathisia), or trouble sleeping (insomnia) in some patients.
• If you are experiencing trouble with sleep, contact your doctor immediately. Lack of sleep may be a symptom of your condition or might worsen your treatment outcome.

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.