Asenapine (Saphris) is an atypical antipsychotic. It's used to treat schizophrenia in adults and bipolar I disorder in people ages 10 years and older. It comes as sublingual (under the tongue) tablets in both a brand-name and generic versions. The usual dosage is to dissolve a tablet under the tongue twice a day. Some potential side effects of this medication include sleepiness, trouble sleeping, and movement problems.
Schizophrenia in adults
Bipolar I disorder in adults and children ages 10 years and older
Asenapine (Saphris) is an atypical antipsychotic. It affects dopamine and serotonin activity in your brain, which can help regulate your thoughts, mood, and behaviors.
Source: DailyMed
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Abnormal or decreased touch sensation
inability to move the eyes
inability to sit still
increase in body movements
increased blinking or spasms of the eyelid
lip smacking or puckering
need to keep moving
puffing of the cheeks
rapid or worm-like movements of the tongue
restlessness
shakiness in the legs, arms, hands, or feet
sticking out of tongue
trembling or shaking of the hands or feet
trouble with breathing, speaking, or swallowing
twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
uncontrolled chewing movements
uncontrolled twisting movements of the neck, trunk, arms, or legs
unusual facial expressions
weakness of the arms and legs
Less common
Blurred vision
dizziness
headache
nervousness
pounding in the ears
slow or fast heartbeat
Rare
Black, tarry stools
bleeding gums
blood in the urine or stools
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
changes in patterns and rhythms of speech
coma
confusion
convulsions
decreased urine output
fast, pounding, or irregular heartbeat or pulse
increased thirst
muscle pain or cramps
nausea or vomiting
pale skin
pinpoint red spots on the skin
slurred speech
swelling of the face, ankles, or hands
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
sleepiness or unusual drowsiness
trouble sleeping
unusually deep sleep
unusually long duration of sleep
Less common
Acid or sour stomach
belching
difficulty with moving
fear or nervousness
increased appetite
increased watering of the mouth
increased weight
indigestion
irritability
muscle pain or stiffness
pain in the arms or legs
pain in the joints
stomach discomfort, upset, or pain
toothache
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Dissolved under the tongue; good option for people who have a hard time swallowing tablets
Possible option for children who have bipolar I disorder
Less likely to cause weight gain than some other antipsychotic medications, like olanzapine (Zyprexa)
Can cause drowsiness or trouble sleeping
Taken twice a day
Can't be taken by people who have severe liver problems
Each asenapine (Saphris) tablet is packaged on its own. The directions for how to remove the tablet from the packaging can differ depending on the manufacturer, so follow the instructions carefully. Don't open the package or remove the tablet until you're ready to take it. If you remove it too early, the tablet might break.
Make sure your hands are dry before touching the asenapine (Saphris) tablet. Otherwise, the tablet might dissolve in your hands.
Place asenapine (Saphris) under your tongue and let it dissolve completely. Don't crush, chew, or swallow the tablets. Otherwise, you won't get the right dose of medication.
Avoid placing asenapine (Saphris) on or near any mouth sores or blisters. Doing so can cause skin irritation, like swelling and pain.
Don't eat or drink for 10 minutes after you take asenapine (Saphris). Doing so causes your body to absorb less medication, which means that asenapine (Saphris) might not work as well to help with your condition.
Some people might feel a numbing or tingling sensation in their mouth after taking asenapine (Saphris). This sensation should go away after an hour.
Asenapine (Saphris) can make you feel sleepy or dizzy. Don't drive or do anything that requires a lot of concentration until you know how the medication affects you.
Asenapine (Saphris) can make it harder for your body to cool down. Drink enough water to stay hydrated during and after working out, and don't stay in the sun for too long to avoid getting overheating.
Asenapine (Saphris) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: People over age 65 years who have dementia
There's higher risk of death in people over 65 years old with dementia taking medications like asenapine (Saphris) to treat psychosis. Most of the time, the causes of death were related to heart problems or infections. Asenapine (Saphris) isn't approved to treat dementia-related psychosis.
Neuroleptic malignant syndrome (NMS) is a rare, but life-threatening condition linked to antipsychotic medications. Symptoms include high fever, fast heart rate, full body stiffness, and confusion. Seek medical attention right away if you notice any of these symptoms. Your prescriber will likely recommend a different medication.
Risk factors: Taking atypical antipsychotic medications for a long time | Older females
Long-term use of asenapine (Saphris) has been linked to the development of tardive dyskinesia (TD). TD is a condition where you feel constantly restless and unable to sit still. Symptoms can include lip smacking, grimacing, and unusual eye blinking. Sometimes, this side effect can become permanent, even after you stop taking asenapine (Saphris). To lower your risk of TD, your healthcare team will only prescribe the lowest dose of medication needed to treat your symptoms. THey'll check in with you regularly to see if you still need to take asenapine (Saphris). Talk to your prescriber right away if you experience symptoms of TD.
Antipsychotic medications like asenapine (Saphris) can cause high blood sugar or diabetes, high cholesterol, and weight gain. These changes might raise your risk of heart disease, stroke, and other serious health issues. Talk to your prescriber about your risks and preventive measures you can take.
Asenapine (Saphris) can rarely cause serious allergic reactions. Get medical help right away if you experience a rash, fast heartbeat, swelling, or trouble breathing.
Risk factors: Older adults | History of heart or heartbeat problems | Taking blood pressure medications or other medications that can lower blood pressure | Taking medications that can affect heart rhythm
Asenapine (Saphris) can cause low blood pressure, especially when getting up from a sitting or lying down position. This medication can also cause changes in your heart beat. Be very careful the first few days you start taking asenapine (Saphris) when you stand up, because you might feel dizzy and possibly faint or fall. If you've had problems in the past with your heart or heart rhythm, talk to your prescriber to see if you should take something else besides asenapine (Saphris). Contact your care team if you feel faint or experience any abnormal heartbeats while using asenapine (Saphris).
Risk factors: Past low white blood cell count
Asenapine (Saphris) can lower the amount of white blood cells in your body. White blood cells help your body fight off infections and diseases. So you're at a higher risk for infection if your white blood cell count is too low. If you notice a fever or you're getting sick more easily, let your prescriber know right away. You might need to have blood tests done before you start asenapine (Saphris) and during the first few months of being on this medication to make sure that you have a healthy amount of white blood cells.
Risk factors: History of seizures | Health conditions that make it easier to have seizures
Asenapine (Saphris) can make you more likely to have seizures. Before starting this medication, let your prescriber know if you have a history of seizures or have a medical condition that puts you at risk for having seizures.
Taking asenapine (Saphris) can raise the levels of a hormone called prolactin in the body. The risk is higher if you take this medication over a longer period of time. Symptoms of too much prolactin can include changes in menstrual bleeding patterns, fertility problems, and mood problems in females. They can also include sexual problems in males. Talk with your health care team if you're concerned about higher prolactin levels.
Some brands of asenapine (Saphris) tablets contain phenylalanine, which can be harmful in people with phenylketonuria (PKU). Make sure your prescriber knows if you have PKU.
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 60 sublingual tablets of 2.5mg | 1 carton | $113.72 | $113.72 |
| 60 sublingual tablets of 5mg | 1 carton | $96.56 | $96.56 |
| 100 sublingual tablets of 5mg | 1 carton | $142.60 | $142.60 |
| 60 sublingual tablets of 10mg | 1 carton | $113.72 | $113.72 |
| 100 sublingual tablets of 10mg | 1 carton | $171.20 | $171.20 |
Schizophrenia: The typical dose is 5 mg under the tongue twice daily. After a week (if needed), your healthcare team might raise your dose to a maximum of 10 mg twice daily.
Bipolar disorder
Adults: The typical dose ranges from 5 mg to 10 mg under the tongue twice daily, with a maximum dose of 10 mg twice daily. Your dose will depend on if you're taking other medications for bipolar.
Children ages 10 to 17 years old: The typical starting dose is 2.5 mg under the tongue twice daily. After 3 days, your child's pediatrician might raise their dose to 5 mg twice daily. The maximum dose is 10 mg twice daily.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Severe liver problems
Schizophrenia in adults
Bipolar I disorder in adults and children ages 10 years and older
Schizophrenia - people ages 13 years and older
Manic or mixed episodes associated with bipolar I disorder - people ages 10 years and older
Irritability associated with autism - children ages 5 to 17 years old
Tourette syndrome in children
Depression (add-on treatment)
Irritability associated with autistic disorder in children
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Allergan, Inc. (2024). Saphris- asenapine maleate tablet [package insert]. DailyMed.
Gonzalez, J. M., et al. (2011). Review of the safety, efficacy, and side effect profile of asenapine in the treatment of bipolar 1 disorder. Patient Preference and Adherence.
Keks, N., et al. (2019). Stopping and switching antipsychotic drugs. Australian Prescriber.
MedlinePlus. (2023). Phenylketonuria.
Vieta, E., et al. (2018). A review of asenapine in the treatment of bipolar disorder. Clinical Drug Investigation.
You and Your Hormones. (2023). Prolactin.
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