Asenapine belongs to group of medications known as antipsychotic agents. It is used to treat schizophrenia and bipolar disorder.

Schizophrenia can cause symptoms such as hallucinations (e.g., hearing, seeing, or sensing things that are not there), delusions, unusual suspiciousness, and emotional withdrawal. People with this condition may also feel depressed, anxious, or tense.

Bipolar disorder causes alternating periods of depression and mania (abnormally elevated or irritable mood) or "mixed episodes" where people have symptoms of both depression and mania. Asenapine is used to treat the manic or mixed episodes (but not the depression) of bipolar disorder.

Conditions that affect the brain, such as schizophrenia, may be due to certain neurotransmitters (chemicals that control the function of nerve pathways) in the brain being out of balance. These imbalances may cause some of the symptoms of schizophrenia or bipolar disorder. Medications like asenapine are thought to work by correcting the balance of neurotransmitters.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The usual recommended dose for schizophrenia treatment is 5 mg taken twice daily.

The usual starting dose for bipolar disorder treatment is 5 mg twice daily. Depending on how well the medication works for you and how well it is tolerated, your doctor may recommend increasing the dose to 10 mg twice daily.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Asenapine tablets should be placed under the tongue and allowed to dissolve completely. The saliva in the mouth will dissolve the tablet within seconds. Do not crush, chew, or swallow asenapine tablets.

Handle the tablet with dry hands and remove the tablet from the package only when you are ready to take it. To remove it from the package, pull the tab on the package back and remove the tablet gently. Do not crush the tablet.

In order for the medication to be properly absorbed into the body, do not eat or drink anything for 10 minutes after dissolving a tablet under the tongue. If you are taking other medications at the same time, take asenapine last.

It is important that this medication be taken exactly as prescribed by your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you miss 2 or more doses, contact your doctor. Store this medication between 2°C and 30°C in the original package. Keep this medication out of the reach of children.

5 mg
Each round, white-to-off-white, fast-dissolving sublingual tablet debossed with "5" on one side contains 5 mg of asenapine. Nonmedicinal ingredients: gelatin, mannitol.

10 mg 
Each round, white-to-off-white, fast-dissolving sublingual tablet debossed with "10" on one side contains 10 mg of asenapine. Nonmedicinal ingredients: gelatin, mannitol.

Do not take asenapine if you are allergic to asenapine or any ingredients of the medication.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• anxiety
• change in the sense of taste
• dizziness
• drowsiness
• fatigue
• increased appetite
• increased saliva, drooling
• low blood pressure, especially when moving from a lying or sitting position to a standing position
• blisters
• muscle aches
• numbness or tingling in the mouth
• restlessness
• sleepiness
• speech problems
• weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abnormal, slow, or fast heartbeat
• decreased alertness
• difficulty focusing, blurred vision
• difficulty swallowing
• fainting
• muscle spasms
• new or worsening constipation
• slow movements and tremor
• trouble concentrating
• unusual or involuntary movements or muscle contractions

Stop taking the medication and seek immediate medical attention if any of the following occur:

• painful or prolonged erection that lasts more than 4 hours
• seizure
• signs of a blood clot in blood vessels (e.g., sudden vision change or dizziness, chest pain, difficulty breathing, heart palpitations, pain and swelling in leg or arm)
• signs of neuroleptic malignant syndrome (e.g., confusion, reduced consciousness, high fever, or muscle stiffness)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• thoughts of suicide/self-harm

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Alcohol and other medications that cause drowsiness: Do not combine this medication with alcohol or other medications (e.g., antidepressants, sleeping pills, anxiety medications) that cause drowsiness since additive drowsiness can occur and be dangerous.

Allergy: Some people taking this medication have experienced severe allergic reactions. Get medical attention as soon as possible if you experience symptoms of a severe allergic reaction or anaphylactic reaction, such as:

• difficulty breathing
• itching
• swelling of the face, tongue, or throat
• feeling lightheaded or dizzy

Blood clots: This medication may increase the chance of blood clot formation, causing reduced blood flow to the organs or extremities. If you have a history of clotting or if you have risk factors for developing blood clots (e.g., family history, age over 65, obesity, recent major surgery, smoking, taking birth control pills), you may be at increased risk of experiencing blood-clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.

Body temperature: This medication, like other antipsychotic medications, may disrupt the body's ability to control body temperature. If you exercise vigorously, are exposed to extreme heat, are dehydrated, or are taking anticholinergic medications (e.g., benztropine, oxybutynin), you are more at risk. Contact your doctor as soon as possible if you feel very hot and are unable to cool down while taking this medication.

Drowsiness/reduced alertness: Asenapine may impair the mental and physical abilities required for driving a car or operating machinery. Do not drive, operate machinery, or perform other hazardous tasks until you have determined how this medication affects you. Avoid drinking alcohol while taking this medication, as it may produce extreme drowsiness.

Heart rhythm: Asenapine can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., if you have heart failure, angina, or low potassium or magnesium levels, or if you take other medications that can affect heart rhythm), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

High blood sugar: Asenapine may cause an increase in blood sugar levels. Your doctor may monitor your blood sugar levels while you are taking asenapine. If you have diabetes or are at an increased risk of developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience weakness, increased thirst, increased urination, and increased appetite while taking this medication, contact your doctor as soon as possible, as these are signs that your blood glucose level may be high.

Hypersensitivity reaction: Rarely, people taking asenapine have reported a severe skin reaction. In rare cases, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome) may occur. This reaction involves symptoms including fever, swollen glands, yellowing of the skin or eyes, flu-like symptoms with skin rash or blistering, or other organ involvement. These reactions are medical emergencies. Get immediate medical attention if you have symptoms of a severe allergic reaction. If you experience any unusual symptoms, contact your doctor.

Infection: Asenapine can reduce the number of cells that fight infection in the body (white blood cells). Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Liver disease: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication. Asenapine should not be used by people with severely reduced liver function.

Low blood pressure: Asenapine may cause low blood pressure, especially when moving from a lying or sitting position to a standing position. Low pressure may cause dizziness, lightheadedness, or even fainting for some people. If you have heart disease, cerebrovascular disease, or conditions that increase the risk of developing low blood pressure (e.g., dehydration, treatment with blood pressure medications) you should be monitored by your doctor.

Neuroleptic malignant syndrome (NMS): Asenapine, like other antipsychotic medications, may cause a potentially fatal syndrome known as neuroleptic malignant syndrome (NMS). If you notice the symptoms of NMS such as high fever, confusion or loss of consciousness, racing or irregular heartbeat, muscle stiffness, or sweating, get immediate medical attention.

Medical conditions: Like other similar medications, asenapine can increase the levels of the hormone prolactin in your body. If you have a medical condition called hyperprolactinemia (increased blood levels of the hormone prolactin), asenapine may make the symptoms worse. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Mouth numbness: Asenapine can cause a sensation of numbness in the mouth immediately after letting a tablet dissolve in your mouth. This usually goes away within an hour of taking the medication. Avoid eating or drinking anything for at least 10 minutes after taking the medication.

Prolonged erection: In rare cases, use of this medication by some men may cause them to develop priapism (a prolonged and painful erection). If you have an erection that lasts for more than 4 hours, seek immediate medical attention.

Seizures: Asenapine may increase the risk of seizures, especially if you have had seizures in the past. If you are at risk of seizures or have a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Suicide/self-harm: People with schizophrenia or bipolar disorder are at risk of suicide and self-harm. If you feel like harming yourself or if you notice this behaviour in a friend or family member, seek immediate medical attention. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.

Tardive dyskinesia (TD): People who take certain antipsychotic medications, including asenapine, may develop TD, a syndrome consisting of potentially irreversible, involuntary, repetitive movements of the muscles. Although TD appears most commonly in seniors, especially women, it is impossible to predict who will develop TD. The risk of developing TD increases with higher doses and long-term treatment. If you experience muscle twitching or abnormal movements of the muscles in the face, tongue, or extremities, contact your doctor as soon as possible.

Weight gain: People who take this medication as a long-term treatment have experienced weight gain.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if asenapine passes into breast milk. If you are breast-feeding and taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children under the age of 18.

Seniors: There may be a higher risk of death associated with the use of asenapine by seniors with dementia. Deaths have usually been related to cardiovascular causes or infection. Seek medical attention immediately if you notice the signs and symptoms of a stroke (e.g., sudden weakness or numbness, speech problems, vision problems, dizziness, confusion, sudden severe headache), heart attack (e.g., discomfort or pain in the chest, back, neck, jaw, arms; sweating; shortness of breath; nausea; lightheadedness), or infection (e.g., pneumonia). Asenapine should not be used by seniors with dementia.

There may be an interaction between asenapine and any of the following:

• alcohol
• aldesleukin
• aldosterone antagonists (e.g., eplerenone, spironolactone)
• aliskiren
• alpha agonists (e.g., clonidine, methyldopa)
• alpha blockers (e.g., doxazosin, prazosin, tamsulosin, terazosin)
• amiodarone
• amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
• angiotensin converting enzyme inhibitors (ACEIs; captopril, cilazapril, enalapril, ramipril)
• angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
• antihistamines (e.g., azelastine, cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine, rupatadine)
• Anti-Parkinsons medications (e.g., amantadine, apomorphine, bromocriptine, cabergoline, entacapone, levodopa, pramipexole, ropinirole, rotigotine)
• barbiturates (e.g., butalbital, phenobarbital)
• benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
• beta-adrenergic blockers (e.g., atenolol, carvedilol, propranolol, sotalol)
• brimonidine
• buprenorphine
• bupropion
• butorphanol
• caffeine
• calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
• cannabis
• chloral hydrate
• ciprofloxacin
• diabetes medications (e.g., acarbose, canagliflozin, glyburide, liraglutide, lixisenatide, insulin, metformin, rosiglitazone)
• dimenhydrinate
• diphenoxylate
• disopyramide
• diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
• donepezil
• dronedarone
• efavirenz
• esketamine
• flecainide
• flibanserin
• flunarizine
• galantamine
• general anesthetics (medications used to put people to sleep before surgery)
• guanfacine
• hydralazine
• lemborexant
• kava kava
• linezolid
• lithium
• methadone
• methylphenidate
• metoclopramide
• mirtazapine
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, rasagiline, selegiline, tranylcypromine)
• muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
• nabilone
• narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone, tapentadol, tramadol)
• nitrates (e.g., nitroglycerine, isosorbide dinitrate)
• other antipsychotics (e.g., cariprazine, chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
• obinutuzumab
• pizotifen
• polyethylene glycol electrolyte solution
• pomalidomide
• pramipexole
• pregabalin
• procainamide
• protein kinase inhibitors (e.g., lenvatinib, selpercatinib, vandetanib)
• quinine
• riociguat
• rivastigmine
• ropinirole
• rotigotine
• sacubitril
• scopolamine
• seizure medications (e.g., clobazam, gabapentin, levetiracetam, perampanel, primidone, topiramate, valproic acid)
• selective serotonin re-uptake inhibitors (SSRIs; e.g., citalopram, fluvoxamine, paroxetine, sertraline, vortioxetine)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
• sodium oxybate
• tetrabenazine
• thalidomide
• theophyllines (e.g., aminophylline, theophylline)
• tizanidine
• tramadol
• trazodone
• tretinoin
• tricyclic antidepressants (e.g., amitriptyline, doxepin, nortriptyline)
• triptorelin
• tryptophan
• valerian
• vilazodone
• zolpidem
• zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.