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Elderly people with dementia-related psychosis (a severe mental health problem) taking atypical antipsychotic drugs, including SAPHRIS, are at an increased risk for death compared with those taking placebo (sugar tablet). SAPHRIS is not approved for the treatment of people with dementia-related psychosis (see Boxed Warning). 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 treatment of manic or mixed episodes associated with bipolar I disorder in adults. It may be taken alone or with lithium or valproate.

Important Risk Information

Elderly people with dementia-related psychosis (a severe mental health problem) taking atypical antipsychotic drugs, including SAPHRIS, are at an increased risk for death compared with those taking placebo (sugar tablet). SAPHRIS is not approved for the treatment of people with dementia-related psychosis (See Boxed Warning). An increased risk for stroke and ministroke has been reported in elderly people with dementia-related psychosis.

Serious allergic reaction: Do not take SAPHRIS (asenapine) if you are allergic to any of its ingredients. Seek immediate emergency assistance if you have symptoms of a serious allergic reaction, such as difficulty breathing; itching; swelling of the face, tongue, or throat; or light-headedness.

Neuroleptic malignant syndrome (NMS): Tell your healthcare provider right away if you have high fever; stiff muscles; confusion; changes in pulse, heart rate, or blood pressure; sweating; or muscle pain and weakness. These can be signs of a rare and potentially fatal side effect (NMS) that has been reported with SAPHRIS and similar medicines. Treatment should be stopped if you have NMS.

Tardive dyskinesia (TD): Tell your healthcare provider if you experience uncontrollable movements of the face, tongue, or other parts of the body. These could be signs of a serious and sometimes permanent side effect (TD). The risk for developing TD and the chance that it will become permanent is thought to increase the longer a person takes the medicine and the more medicine a person takes over time. TD can develop after a person has been taking the medicine for a short time at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if the person stops taking the medicine.

High blood sugar: If you have diabetes or risk factors for diabetes, such as being overweight or a family history of diabetes, your blood sugar should be tested at the beginning of and throughout treatment with SAPHRIS. Complications of diabetes can be serious and even life threatening. Tell your healthcare provider if you have blood sugar problems or signs of diabetes, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry.

Weight gain: Some patients may gain weight while taking SAPHRIS. Your healthcare provider should check your weight regularly.

Also tell your healthcare provider if:
  • You have or had low white blood cell counts, because low white blood cell counts and related conditions have been reported with SAPHRIS and similar medicines
  • You have any reactions under your tongue (where you place SAPHRIS), such as sores, blisters, peeling/sloughing or inflammation, because these reactions have been reported with SAPHRIS
  • You have certain heart conditions such as irregular heartbeats, or take certain medicines that can cause irregular heartbeats, because SAPHRIS should be avoided in these circumstances
  • You have a seizure disorder, have had seizures, or have conditions that increase your risk for seizures
  • You are taking or plan to take prescription and over-the-counter medicines, because there is a risk for drug interactions with SAPHRIS
  • You have thoughts of suicide or of hurting yourself or others. Symptoms of bipolar I disorder or schizophrenia may include these thoughts. If you have these thoughts at any time, tell your healthcare provider or go to an emergency room right away
  • You have or have had swallowing problems, because SAPHRIS and medicines like it have been associated with swallowing problems
  • You experience a lack of menstrual periods, leaking or enlarged breasts, or impotence, because SAPHRIS and medicines like it may raise the levels of prolactin. The levels may continue to be high when SAPHRIS is used over time
  • You are pregnant or planning to get pregnant while taking SAPHRIS
Other important information to remember:
  • Get up slowly after sitting or lying down to avoid getting dizzy, especially at the start of treatment, or when your dose is increased. Light-headedness or faintness caused by a sudden change in heart rate and blood pressure when rising quickly from a sitting position has been reported with SAPHRIS
  • Do NOT drive or use dangerous machines until you know how SAPHRIS affects you, because SAPHRIS and medicines like it can affect your judgment, thinking, and motor skills
  • Be careful when exercising or when doing things likely to cause dehydration or make you warm, because SAPHRIS may make you more sensitive to heat. You may have trouble cooling off
  • Do NOT drink alcohol
  • Breastfeeding is NOT recommended
  • The most common side effects that occurred with SAPHRIS were sleepiness, dizziness, uncontrolled movements of the body and face, muscle stiffness, weight gain, numbing of the mouth, and restlessness

This is not a complete summary of safety information. Please discuss the full Prescribing Information for SAPHRIS with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit, or call 1‑800‑FDA‑1088.

© 2013 Merck Sharp & Dohme B.V.; used by Forest Laboratories, Inc. under license.
© 2015 Forest Laboratories, Inc.
The trademarks SAPHRIS, SAPHRIS & Star Design, and Star Design are used by Forest Laboratories, Inc.
under license from Merck Sharp & Dohme B.V.
SPH17003 05/14