Generic Name: asenapine (a SEN a peen)Brand Names: Saphris
Asenapine is an antipsychotic medication. It works by changing the actions of chemicals in the brain.
Asenapine is used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression) in adults.
Asenapine may also be used for other purposes not listed in this medication guide.
Before taking asenapine, tell your doctor if you have liver disease, heart disease, high blood pressure, seizures, low white blood cell counts, diabetes, trouble swallowing, or a history of heart breast cancer, heart attack, stroke, or "Long QT syndrome."Avoid drinking alcohol, which can increase some of the side effects of asenapine. Stop taking asenapine and call your doctor at once if you have fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, restless muscle movements in your face or neck, tremor (uncontrolled shaking), trouble swallowing, feeling light-headed, or fainting.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:
heart disease, high blood pressure, heart rhythm problems;
a history of heart attack or stroke;
a history of breast cancer;
seizures or epilepsy;
diabetes (asenapine may raise your blood sugar);
a history of low white blood cell (WBC) counts; or
a personal or family history of"Long QT syndrome."
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
Asenapine is usually taken 2 times per day. Follow your doctor's instructions.
To take asenapine sublingual (under the tongue) tablets:
Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the colored tab from the tablet blister. Do not push a tablet through the blister or you may damage the tablet.
Using dry hands, gently remove the tablet and place it under your tongue. It will begin to dissolve right away.
Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
Do not eat or drink anything for 10 minutes after the tablet has dissolved.
Asenapine may cause you to have high blood sugar (hyperglycemia). Symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. If you are diabetic, check your blood sugar levels on a regular basis while you are taking asenapine.
To be sure this medication is helping your condition, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.Store asenapine at room temperature away from moisture and heat.
See also: Asenapine dosage in more detail
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.Avoid drinking alcohol, which can increase some of the side effects of asenapine.
very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
tremor (uncontrolled shaking);
sudden numbness or weakness, especially on one side of the body;
sudden and severe headache, or problems with vision, speech, or balance;
easy bruising or bleeding, fever, chills, body aches, flu symptoms;
white patches or sores inside your mouth or on your lips;
seizure (convulsions); or
unusual thoughts or behavior, hallucinations, or thoughts about hurting yourself.
Less serious side effects may include:
numbness or tingling inside or around your mouth;
sleep problems (insomnia);
upset stomach; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Schizophrenia:
Recommended starting and target dose: 5 mg by sublingual tablet twice dailyTo ensure optimal absorption, the tablet should be placed under the tongue and allowed to dissolve completely. The tablet will dissolve in saliva within seconds. Asenapine sublingual tablets should not be crushed, chewed, or swallowed. Patients should not eat or drink for 10 minutes after administration.In controlled trials, there was no suggestion of added benefit with the higher dose, but there was a clear increase in certain adverse reactions. The safety of doses above 10 mg twice daily has not been evaluated in clinical studies.Maintenance Treatment:While there is no body of evidence available to answer the question of how long the schizophrenic patient should remain on asenapine, it is generally recommended that responding patients be continued beyond the acute response.
Usual Adult Dose for Bipolar Disorder:
Usual Dose for Acute Treatment:Recommended starting dose: 10 mg by sublingual tablet twice dailyMaintenance dose of 90% of the patients studied: 10 mg by sublingual tablet twice dailyTo ensure optimal absorption, the tablet should be placed under the tongue and allowed to dissolve completely. The tablet will dissolve in saliva within seconds. Asenapine sublingual tablets should not be crushed, chewed, or swallowed. Patients should not eat or drink for 10 minutes after administration.The dose can be decreased to 5 mg twice daily if there are adverse effects.In controlled trials, the starting dose for asenapine was 10 mg twice daily. On the second and subsequent days of the trials, the dose could be lowered to 5 mg twice daily, based on tolerability, but less than 10% of patients had their dose reduced. The safety of doses above 10 mg twice daily has not been evaluated in clinical trials.Maintenance:While there is no body of evidence available to answer the question of how long the bipolar patient should remain on asenapine, it is generally recommended that responding patients be continued beyond the acute response.
The following drugs can interact with asenapine. Tell your doctor if you are using
arsenic trioxide (Trisenox);
blood pressure medications;
an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), or pentamidine (NebuPent, Pentam);
an antidepressant such as amitriptylline (Elavil, Vanatrip), clomipramine (Anafranil), desipramine (Norpramin), fluoxetine (Prozac), or paroxetine (Paxil);
anti-malaria medications such as chloroquine (Arelan), or mefloquine (Lariam);
heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), ibutilide (Corvert), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quinidex, Quin-Release Quin-G), or sotalol (Betapace);
medicine to prevent or treat nausea and vomiting, such as dolasetron (Anzemet) or ondansetron (Zofran);
other medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon);
migraine headache medicine such as sumatriptan (Imitrex) or zolmitriptan (Zomig); or
narcotic medication such as levomethadyl (Orlaam), or methadone (Dolophine, Methadose).
This list is not complete and there may be other drugs that can interact with asenapine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.