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Overview: Asenapine is used to treat schizophrenia or bipolar disorder. It is a tablet that dissolves under the tongue. Common side effects include restlessness, numbness or tingling in your mouth, drowsiness, or dizziness. Asenapine can affect your alertness or coordination. It can also affect your body’s ability to regulate temperature. Try to avoid getting overheated, stay hydrated, and wear light and breathable clothing while you are taking asenapine.

Uses

What is asenapine used for?

Asenapine is commonly used for the following mental health conditions.

Asenapine may also be used for other conditions as determined by your health care provider.

Asenapine is also available as a patch that is applied to the skin. See Secuado for more information.

How does asenapine work (mechanism of action)?

Asenapine belongs to a group of medicines called second-generation (atypical) antipsychotics. It is thought to work by balancing brain chemicals called serotonin and dopamine. These chemicals are known to affect thoughts and mood.

How is asenapine supplied (dosage forms)?

Brands and other names

  • Saphris

Dosage forms and strengths

  • 2.5 mg sublingual tablets
  • 5 mg sublingual tablets
  • 10 mg sublingual tablets

How should I store asenapine?

Asenapine should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of asenapine?

The most common side effects of asenapine are listed below. These side effects may vary based on the condition being treated and your age. Tell your health care provider if you have any of these side effects that bother you.

  • Restlessness (akathisia)
  • Numbness or tingling in your mouth
  • Drowsiness, sleepiness, or tiredness
  • Dizziness
  • Movement problems
  • Change in how things taste
  • Nausea
  • Increased appetite
  • Weight gain

There may be other side effects of asenapine that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of asenapine?

While less common, the most serious side effects of asenapine are described below, along with what to do if they happen.

Severe Allergic Reactions. Asenapine may cause allergic reactions, which can be serious. Stop taking asenapine and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Heart Rhythm Changes. Asenapine may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or who take medicines that can prolong the QT interval. Tell your health care provider right away if you faint or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.

Metabolism Changes. Asenapine can cause high blood sugar levels or diabetes, high cholesterol levels, and weight gain. Keep all appointments with your health care provider to check your blood work and weight. Call your health care provider if you gain weight or develop the following symptoms of high blood sugar.

  • Thirsty more than usual
  • Peeing more than usual
  • Increase in hunger
  • Tiredness
  • Feeling sick to your stomach
  • Confusion
  • Your breath smelling fruity

Uncontrolled Movements. Asenapine can cause some people to have movements that they cannot control. This condition, called tardive dyskinesia (TD), can cause jerky movements of the face, tongue, or body. TD can be permanent. Call your health care provider right away if you have any of the following symptoms of TD.

  • Tongue sticking out
  • Lip smacking or puckering
  • Grimacing
  • Rapid eye blinking
  • Jerking or twisting motion of the arms, legs, or trunk

Low Blood Pressure Upon Standing (Orthostatic Hypotension) and Falls. Asenapine may cause a sudden drop in blood pressure when standing up from a seated or lying position. Some people faint or even fall when this happens, which may cause bone fractures or other injuries. To help prevent this, be careful not to get up too quickly. If you feel dizzy, sit or lie down right away until the dizziness stops, then take your time getting up again. Tell your health care provider right away if you have any of the following symptoms of orthostatic hypotension.

  • Dizziness, feeling lightheaded, or fainting upon standing
  • Blurred vision
  • Confusion
  • Feeling weak

Seizures. Some people who have taken asenapine have reported having seizures. There are many different types of seizures and some of them are not easy to recognize. Stop taking asenapine and call your health care provider if you have any of the following signs that a seizure is happening or could happen.

  • Muscle twitching, jerking, spasms, tremors, or other uncontrolled movements
  • Stiffening of your arms and legs
  • Feeling anxious, nervous, confused, or a sense of dread
  • Feeling dizzy or lightheaded
  • Falling or losing consciousness

Decreased Alertness or Coordination. Asenapine can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how asenapine affects you.

Trouble Swallowing. Asenapine can cause trouble swallowing (dysphagia), which can increase your risk of choking while eating or drinking. Eat small amounts of food, and chew your food well. Get emergency help if you are choking or have food stuck in your esophagus that is not passing.

Body Temperature Regulation. Asenapine can affect your ability to regulate your body temperature. This could make you become very hot, especially in hot weather or after exercising a lot. You should drink water and avoid overheating and dehydration. Call your health care provider right away if you are severely ill and have the following symptoms of dehydration.

  • Excessive or no sweating
  • Dry mouth
  • Feeling very hot
  • Feeling thirsty 
  • Not able to pee

Blood Disorders. Asenapine can cause blood disorders such as low white blood cell levels (leukopenia,  neutropenia, or agranulocytosis). Keep all appointments with your health care provider to check your blood work. Stop taking asenapine and get help right away if you have any of the following symptoms of blood disorders.

  • Fever
  • Shortness of breath
  • Frequent infection
  • Unusual weakness or tiredness
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Headache
  • Fast or abnormal heartbeat

Neuroleptic Malignant Syndrome (NMS). Antipsychotic medicines, like asenapine, may cause a rare but serious condition called neuroleptic malignant syndrome. NMS can lead to death. Stop taking asenapine and contact your health care provider right away if you have any of the following symptoms.

  • High fever
  • Muscle stiffness or rigidity, where it is hard to move
  • Confusion 
  • Changes in your breathing or heart rate
  • Increased sweating

High Prolactin Level (Hyperprolactinemia). Asenapine may cause an increased level of the hormone prolactin in your blood. High levels of prolactin could lead to fertility or bone problems. Contact your health care provider if you have any of the following symptoms.

  • Vaginal dryness
  • Irregular or no periods
  • Production of breast milk when not pregnant or nursing
  • Inability to get or keep an erection
  • Enlarged breast size (gynecomastia)
  • Decreased muscle and body hair

Warnings & Precautions

Who should not use asenapine?

Allergies to Ingredients. People who are allergic to any of the following should not take asenapine.

  • Asenapine
  • Saphris
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific asenapine products they stock.

Severe Liver Problems. Asenapine should not be taken if your liver is not working as well as it should be. If there is a concern about the health of your liver, your health care provider may do tests to determine if it is working well enough to take this medicine.

What should I know about asenapine before using it?

Do not take asenapine unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share asenapine with other people, even if they have the same condition as you. It may harm them.

Keep asenapine out of the reach of children.

Because asenapine can make it hard for you to regulate your body temperature, try to avoid becoming too hot or dehydrated. Drink plenty of water, limit your exposure to the heat and sun, do not overexercise, and wear light and breathable clothing.

Do not remove asenapine from its packaging until you are ready to take it. Make sure your hands are dry when handling asenapine. Do not chew, crush, cut, or swallow the tablet. Place the tablet under your tongue and let it melt completely. Do not eat or drink for 10 minutes after taking asenapine. Read and follow the instructions that come with the medicine and make sure that you understand how to take it properly. If you have any questions, talk to your health care provider.

You may have tingling or numbness in your mouth or throat after taking asenapine. This usually goes away within one hour. Tell your health care provider right away if you have any more serious reactions, such as mouth blisters, sores, or redness. 

People who are 65 or older can be at greater risk for some side effects from asenapine. Talk to your health care provider about your risks if you are in this age group.

What should I tell my health care provider before using asenapine?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if asenapine is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have or have had any of the following.

Psychosis Related to Dementia. There is a higher risk of death, stroke, or ministroke in older adults who take asenapine or another antipsychotic and have memory loss or psychosis related to dementia. Asenapine is not approved to treat dementia-related psychosis.

Pregnancy. Asenapine taken later in pregnancy may lead to an increased risk of certain problems in your newborn.  Tell your health care provider if you are or plan to become pregnant while taking asenapine. Your health care provider will advise you if you should take asenapine while you are pregnant or trying to get pregnant. If you become pregnant while taking asenapine, you can register with the National Pregnancy Registry for Psychiatric Medications by calling 866-961-2388 or at womensmentalhealth.org/research/pregnancyregistry. This registry collects safety information about the use of psychiatric medicines during pregnancy.

Breastfeeding. It is not known if asenapine passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will advise you if you should take asenapine while breastfeeding.

Other Medicines and Supplements. Asenapine may interact with other medicines and supplements. Before taking asenapine, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Interactions

Does asenapine interact with foods or drinks?

There are no known interactions between asenapine and foods or drinks.

It is unknown if drinking alcohol will affect asenapine. Drinking alcohol while taking asenapine could increase your risk of sleepiness, dizziness, feeling lightheaded, or fainting upon standing.

Do not eat or drink for at least 10 minutes after taking the medicine as it needs time to be absorbed.

Does asenapine interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking asenapine.

  • Paroxetine, which is a medicine commonly used for anxiety and depression
  • Fluvoxamine (Luvox), which is a medicine commonly used for obsessive-compulsive disorder (OCD)
  • A medicine for high blood pressure
  • Any medicine that can cause QT prolongation, which is a potentially dangerous heart rhythm problem, such as amiodarone, chlorpromazine, moxifloxacin, quinidine, sotalol, thioridazine, ziprasidone
  • An anticholinergic medicine, which includes antihistamines and medicines commonly used for overactive bladder, Parkinson’s disease, or stomach problems
  • Any other medicine that causes dizziness and sleepiness, such as prescription pain medicines, sleep medicines, and medicines for anxiety

Some other medicines may alter the blood levels of asenapine, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with asenapine. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much asenapine?

If you or someone else has used too much asenapine, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of asenapine?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.