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Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking antipsychotic drugs, including SAPHRIS, are at an increased risk for death. SAPHRIS is not approved for treating people with dementia-related psychosis. Continued below
My health matters to me.

What is bipolar I disorder?

If you have bipolar I disorder or care about someone who does, you know firsthand how hard it can be. Like other types of mental illness, bipolar I disorder is a disorder of the brain.

Bipolar I disorder is a serious illness. And it does not go away. With bipolar I disorder, there may be times when you feel like you’re in the driver’s seat. You know where you’re going and how to get there. At other times, you may feel like you’ve hit bumps in the road. Throughout your life, you will need to manage the symptoms. Learn more about the symptoms of bipolar I disorder.

Diagnosing bipolar I disorder A person may have symptoms for years before receiving a correct diagnosis of bipolar I disorder. For many people with bipolar I disorder, the path to a diagnosis is long and hard.

Causes of bipolar I disorder Scientists are working hard to find the causes of bipolar I disorder. But so far they still do not know exactly what causes it. Like other illnesses, bipolar I disorder may have several causes. Most experts believe that it is caused by a combination of factors.

Here is what is believed about the causes of bipolar I disorder:
  • Differences in brain chemistry and structure may be involved. Some imaging studies show that the brains of people with bipolar I disorder are different from the brains of people without it
  • Bipolar I disorder is known to run in families. Studies show that genes play a role in the disorder
  • In someone at genetic risk for bipolar I disorder, a stressful event—such as the loss of a loved one, an illness, money problems, or other major life changes—may set off the first episode of the disorder
  • In some people, drug or alcohol use may trigger the disorder. Learn steps you can take for healthy living

Counseling and the help of a support team may make a difference for people living with bipolar I disorder. Taking medicine may also be important. Learn more.

For family and friends
Be aware of triggers

Certain events (such as a death in the family or a job loss) and certain behaviors (such as drug or alcohol use) may cause symptoms to appear or to get worse. Watch for triggers in your family member or friend.

Read showing your support to learn why it’s important to have a plan for getting help.

SAPHRIS is a prescription medicine approved for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. It may be taken alone or with lithium or valproate.


What is the most important information I should know about SAPHRIS?
Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking antipsychotic drugs are at an increased risk for death. SAPHRIS is not approved for treating people with dementia-related psychosis.

SAPHRIS may cause serious side effects, including:

  • Stroke (which can be fatal) in elderly people with dementia
  • Neuroleptic malignant syndrome (NMS): Call your healthcare provider right away if you have high fever; stiff muscles; confusion; changes in pulse, heart rate, or blood pressure; or sweating. These can be symptoms of a rare but potentially fatal side effect called NMS. SAPHRIS should be stopped if you have NMS
  • Tardive dyskinesia (TD): Tell your healthcare provider if you cannot control the movements of your face, tongue, or other body parts. These could be signs of a serious and sometimes permanent side effect called TD. Risk of developing TD and the chance that it will become permanent are thought to increase the longer a person takes the medicine and the more medicine a person takes over time. TD can develop even after a person has been taking the medicine for a short time at low doses. TD may not go away, even if you stop taking SAPHRIS. TD may also start after you stop taking SAPHRIS
  • Problems with your metabolism, which may increase your risk for heart disease or stroke, such as:
    • High blood sugar and diabetes: If you have diabetes or risk factors for diabetes (eg, being overweight or family history of diabetes), your blood sugar should be tested before you start SAPHRIS and regularly during treatment. Complications of diabetes can be serious and even life threatening. Tell your healthcare provider if you have symptoms such as feeling very thirsty or very hungry, urinating more than usual, or feeling weak
    • Increased blood cholesterol or triglycerides: Your healthcare provider may decide to check your cholesterol and triglyceride levels during treatment
    • Weight gain: Weight gain has been reported with SAPHRIS. Your healthcare provider should check your weight regularly
  • Decreased blood pressure: You may feel lightheaded or faint when you rise too quickly from a sitting or lying position. Ask your healthcare provider about ways to reduce feeling dizzy or lightheaded upon standing, such as sitting on the edge of the bed for several minutes before getting up in the morning or slowly rising after sitting
  • Low white blood cell count: Low white blood cell counts have been reported with antipsychotic drugs, including SAPHRIS. This may increase your risk of infection. Very low white blood cell counts, which can be fatal, have been reported with other antipsychotics
  • Increases in prolactin levels: Tell your healthcare provider if you experience a lack of menstrual periods, leaking or enlarged breasts, or impotence, because SAPHRIS may raise the levels of prolactin. The levels may continue to be high when SAPHRIS is used over time
  • Seizures
  • Impaired judgment, thinking, and motor skills: Do NOT drive or use dangerous machinery until you know how SAPHRIS affects you. SAPHRIS may make you drowsy
  • Increased body temperature: SAPHRIS may make you more sensitive to heat. You may have trouble cooling off. Be careful when exercising or when doing things likely to cause dehydration or make you warm
  • Suicide: Tell your healthcare provider right away or go to an emergency room if you have thoughts of suicide or of hurting yourself or others. People with schizophrenia and bipolar disorder may have these thoughts
  • Difficulty swallowing: SAPHRIS and medicines like it have been associated with difficulty swallowing
Who should not take SAPHRIS?

Do not take SAPHRIS if you have certain liver problems, or if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (eg, difficulty breathing; itching; swelling of the face, tongue, or throat; or light-headedness).

What should I tell my healthcare provider before taking SAPHRIS?

Tell your healthcare provider about any medical conditions and if you have or have had:

  • Diabetes or high blood sugar in you or your family
  • High levels of total cholesterol, triglycerides, or LDL-cholesterol; or low levels of HDL-cholesterol
  • Seizures or conditions that increase your risk for seizures
  • Low or high blood pressure
  • Low white blood cell count
  • Certain heart problems such as irregular heartbeats or are at risk for these problems, or if you take medicines that can cause irregular heartbeats, because SAPHRIS should be avoided in these circumstances

Tell your healthcare provider if you are pregnant, or if you plan to become pregnant. SAPHRIS may cause harm to your unborn baby. A special program (National Pregnancy Registry for Atypical Antipsychotics) collects information on the safety of antipsychotic drugs, including SAPHRIS, during pregnancy. For information, contact the program at
1-866-961-2388 or

Tell your healthcare provider about all medicines that you take or have recently taken, including prescriptions, over-the-counter medicines, and supplements. SAPHRIS may affect the way other medicines work, and other medicines may affect how SAPHRIS works.

What are possible side effects of SAPHRIS?
  • The most common side effects in adults were sleepiness, dizziness, uncontrolled movements of the body and face, muscle stiffness, weight gain, numbing of the mouth, and restlessness
  • Since FDA approval, patients taking SAPHRIS have reported reactions under the tongue (where you place SAPHRIS), such as sores, oral blisters, peeling/sloughing, or inflammation. Choking has also been reported

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all possible side effects of SAPHRIS.

Please see the full Prescribing Information, including Boxed Warning.

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The health information described on this site is provided for educational purposes only and is not intended to substitute for discussions with a healthcare provider.
Actavis® and its design are trademarks of Actavis, Inc. or its affiliates.
The trademarks SAPHRIS, SAPHRIS & Star Design, and Star Design are used by Actavis, Inc. or its affiliates under license from Merck Sharp & Dohme B.V.
© 2011, 2013 Merck Sharp & Dohme B.V.; used by Actavis, Inc. or its affiliates under license.
© Actavis 2015. All rights reserved.
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