Saphris (Asenapine) – Sublingual

Warning:

Older persons who take this medication for mental issues caused by dementia have a greater mortality risk caused by heart disease, strokes, or infection. This medication is not approved to treat dementia-related mental problems.

What Is Saphris?

Saphris (asenapine) is a prescription drug used in adults and children 10 years and older to treat symptoms of schizophrenia and bipolar disorder. It is a second-generation atypical antipsychotic. Saphris is available as a sublingual (under-the-tongue) dissolvable tablet in black cherry flavor. 

Asenapine works by balancing the levels of certain hormones (serotonin and dopamine) in the brain. It improves the mood, behavior, and thoughts of people with schizophrenia and bipolar disoder.

Drug Facts

Generic Name: Asenapine

Brand Name(s): Saphris

Drug Availability: Prescription

Therapeutic Classification: Second-generation atypical antipsychotic

Available Generically: Yes

Controlled Substance: N/A

Administration Route: Oral

Active Ingredient: Ribociclib

Dosage Form(s): Sublingual tablet

What Is Saphris Used For?

Saphris (asenapine) is a sublingual tablet used to treat bipolar disorder and schizophrenia symptoms. These conditions are complex brain syndromes caused by genes, the environment, or both. Saphris is approved for use in people age 10 years and older. In adults, Saphris may be prescribed alone or in addition to other mood stabilizers like lithium or valproate.

How to Take Saphris 

Take as directed by your healthcare provider and as follows: 

  • Using clean and dry hands, remove the drug from the blister pack.
  • Place the tablet under your tongue.
  • Allow it to dissolve completely, then swallow.
  • Do not eat or drink for at least 10 minutes after taking this medicine.
  • Do not break, chew, or crush the tablet.
  • Do not swallow the tablet whole.
  • Leave the drug in its original container until you are ready to take it. Do not save for future use.

Do not abruptly stop taking this medicine. If you need to discontinue this drug, your healthcare provider may slowly taper you off of it.

Storage

Store at room temperature (68 to 77 degrees Fahrenheit) in a dry place. Do not store in moist areas, such as a bathroom.

Keep your medicines out of reach of children and pets.

Discard all unused and expired drugs. Do not toss them in the trash, flush them down the toilet, or send them down the drain. If you do not know the best ways of disposing of your medicine, ask your pharmacist. There may be drug take-back programs in your area.

Off-Label Use

Saphris is used off-label to control aggression and agitation due to mental disorders and substance intoxication in adults.

How Long Does Saphis Take to Work?

Saphris is rapidly absorbed by the body once taken. It may take about 30 to 90 minutes to peak in your system. The time varies from person to person. Contact your healthcare provider if you have questions about this medicine.

What Are the Side Effects of Saphris?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the Food and Drug Administration (FDA) at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

Common side effects of Saphris include but are not limited to:

  • Taste changes
  • Fatigue
  • Headache
  • Nausea
  • Vomiting
  • Increased appetite
  • Constipation
  • Numbness or tingling of the mouth
  • Weight gain
  • Trouble sleeping
  • Loss of strength and energy
  • Restlessness
  • Skin redness, itching, pain, swelling, or irritation

Severe Side Effects

Saphris can cause many side effects. Some may be life-threatening. Call your healthcare provider promptly if you have serious side effects. Dial 911 if your symptoms feel life-threatening or if you think you have a medical emergency. Severe side effects include:

  • Severe dizziness
  • Infection
  • Fast heartbeat
  • Shortness of breath
  • Nipple discharge
  • Mouth irritation or sores
  • Seizures
  • Passing out
  • Abnormal movements
  • Twitching
  • Change in balance
  • Trouble swallowing
  • Trouble speaking
  • Abnormal heartbeat or slow heartbeat
  • Menstrual changes
  • Enlarged breasts
  • Sexual dysfunction
  • Signs of high blood sugar, like fruity breath
  • Signs of neuroleptic malignant syndrome, like muscle cramps or stiffness, sweating a lot
  • Signs of tardive dyskinesia, like involuntary body movements and mouth puckering
  • Signs of an allergic reaction, like hives, trouble breathing

Neuroleptic malignant syndrome (NMS) is a serious and sometimes fatal reaction. Call your healthcare provider immediately if you have stiff muscles, fever, heavy sweating, headache, or your heartbeat feels different.

This is not a comprehensive list of all side effects. Talk to your provider if you have questions.

Saphris may also increase the risks for:

  • Falls 
  • Blood disorders
  • Very low blood pressure
  • Heart issues (QT prolongation)
  • Suicidal ideation (thinking about suicide)
  • Body temperature regulation issues
  • Liver problems
  • Esophageal dysmotility/aspiration (trouble with liquids and foods in the throat), especially in people 75 years and older
  • Extrapyramidal symptoms (EPS) include a severe muscle problem called tardive dyskinesia 

Long-Term Side Effects

Tardive dyskinesia (TD): This condition may reduce or go away after stopping this medication, but it may not. The risk of tardive dyskinesia increases with the time you spend on Saphris. However, it can also happen with short-term use at low doses. TD increases with age, and is especially common in older females. 

Contact your healthcare provider if you have issues controlling your body movements or experience problems with your tongue, mouth, jaw, or face, such as puffed cheeks, tongue jutting out, mouth puckering, or chewing. 

Report Side Effects

Saphris may cause other adverse effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Saphris Should I Take?

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The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (sublingual tablets):
    • For bipolar disorder:
      • For patients taking asenapine only:
        • Adults—At first, 5 to 10 milligrams (mg) two times a day. Your doctor may adjust your dose as needed.
        • Children 10 to 17 years of age—2.5 to 10 mg two times a day. Your doctor may adjust your dose as needed and tolerated.
        • Children younger than 10 years of age—Use and dose must be determined by your doctor.
      • For patients taking asenapine together with lithium or valproate:
        • Adults—At first, 5 milligrams (mg) two times a day. If needed, your doctor may adjust your dose to 10 mg two times a day.
        • Children—Use and dose must be determined by your doctor.
    • For maintenance treatment of bipolar disorder:
      • Adults—5 to 10 milligrams (mg) two times a day. Your doctor may increase your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • For schizophrenia:
      • Adults—At first, 5 milligrams (mg) two times a day. Your doctor may increase your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Modifications

Considering reproduction: Asenapine may affect both males' and females' chances of having children. It causes a condition known as hyperprolactinemia, in which the body makes too much of a hormone called prolactin.

Prolactin is responsible for functions like sperm production and menstrual regulation. If you plan to have children, your healthcare professional may prescribe other drugs.

Pregnancy: The safety data of this medicine in pregnancy is limited and, therefore, its routine use during pregnancy is not recommended. Use of this medicine while pregnant, especially during the third trimester, may increase the risk of extrapyramidal symptoms (abnormal muscle movements) in newborns after delivery.

In infants, symptoms may include:

  • Drowsiness
  • Feeding disorder
  • Tremors
  • Breathing issues
  • Muscle tone issues 

These symptoms may lead to the hospitalization of your newborn.

If you were assigned female at birth, are 18 to 45 years old, or were exposed to asenapine while pregnant, enroll in the Atypical Antipsychotics Pregnancy Registry by calling 866-961-2388 or going online to the pregnancy registry.

Nursing: In animal studies, Saphris was present in breast milk. However, there are no studies conducted on people who are breastfeeding. Talk to your medical provider if you plan to breastfeed.

Children: The use of this drug in children under age 10 has not been evaluated.

Older Adults: It may take longer for Saphris to clear out of the system of people over age 65 with psychosis than in younger adults. Taking antipsychotics, like Saphris, in this population is not advised due to the risk of adverse effects, including stroke and death in people with dementia. 

Missed Dose

If you mistakenly forget to take your medicine, take the missed dose as soon as you remember. If the time is close to your next dose, skip the missed dose and return to your normal schedule. Do not take two doses at the same time or extra doses.

Overdose: What Happens If I Use Too Much Saphris?

There is no antidote available for Saphris overdose.

What Happens If I Overdose on Saphris?

If you think you or someone else may have overdosed on Saphris, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Saphris, call 911 immediately.

Precautions

Drug Content Provided and Reviewed by IBM Micromedex®

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

Tell your doctor right away if you have sores or blisters in the mouth, or numbness or tingling of the mouth or throat after using this medicine.

Check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while using this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

For diabetic patients: This medicine may affect your blood sugar levels. Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, check with your doctor.

This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, dizziness or lightheadedness, trouble breathing, trouble swallowing, or any swelling of your hands, face, tongue, or throat while you are using this medicine.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Asenapine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection, or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine can cause changes in the heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

This medicine may cause dizziness, drowsiness, trouble with thinking, or trouble with controlling body movements. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that requires you to be alert, well-coordinated, or able to think well.

This medicine might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you are too hot and cannot cool down.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicines including other narcotics, medicine for seizures (eg, barbiturates), muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What Are Reasons I Shouldn't Use Saphris? 

Some people may not be able to take Saphris due to allergies or other health conditions. Avoid taking Saphris if you:

  • Are allergic to Saphris or any part of its component
  • Have severe liver problems

What Other Medications Interact With Saphris?

Certain medications interact with Saphris and increase the risk of severe side effects. Some drugs to avoid are:

Always consult your healthcare provider before starting any new medicines, including over-the-counter (OTC) medications.

What Medications Are Similar?

Drugs similar to Saphris that are second-generation (atypical) antipsychotics include:

This is a list of drugs also prescribed to treat schizophrenia and bipolar disorder. It is not a list of medicines recommended to take with Saphris. You should not take these drugs together unless your provider advises you to. Talk to your pharmacist or a healthcare provider if you have questions.

Frequently Asked Questions

  • What does Saphris treat?

    Saphris treats symptoms of schizophrenia and bipolar disorder in people 10 years and over.

  • What are the common side effects of Saphris?

    Some common side effects are:

    • Increased appetite
    • Constipation
    • Numbness or tingling of the mouth
    • Weight gain
    • Trouble sleeping
    • Loss of strength and energy
  • Where should I store Saphris?

    Store at room temperature (68 to 77 degrees Fahrenheit) in a dry place. Do not store it in your bathroom.

  • What should I do if I miss a dose of Saphris?

    Take the missed dose once you think of it. Skip the missed dose if it is too close to the next dose. Return to your regular dosing schedule. Do not take extra doses or double the amount.

How Can I Stay Healthy While Using Saphris?

Living with schizophrenia or bipolar disorder is not easy. Taking your medicine routinely and as directed by your healthcare provider is essential.

While on Saphris, inform your healthcare providers about any OTC or recreational drugs you may be taking. Although effective and safe in treating schizophrenia and bipolar disorder symptoms, this drug may cause high blood sugar (diabetes), high cholesterol, infection, and weight gain. These effects may increase your likelihood of developing brain problems or heart disease. Check your blood sugar regularly, as directed.

Talk to your healthcare provider if you have any questions or concerns. For more support, connect with local groups in your area.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

3 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Owen MJ, Sawa A, Mortensen PB. SchizophreniaLancet. 2016;388(10039):86-97. doi:10.1016/S0140-6736(15)01121-6

  2. Musselman M, Faden J, Citrome L. Asenapine: an atypical antipsychotic with atypical formulations. Ther Adv Psychopharmacol. 2021;11:20451253211035269. Published 2021 Sep 11. doi:10.1177/20451253211035269

  3. Food and Drug Administration. Saphris label.

By Queen Buyalos, PharmD
Queen Buyalos is a pharmacist and freelance medical writer. She takes pride in advocating for cancer prevention, overall health, and mental health education. Queen enjoys counseling and educating patients about drug therapy and translating complex ideas into simple language.