Key facts about Asenapine Maleate
What dosages is Asenapine Maleate available in?
Asenapine Maleate is available as a 2.5 mg, 5 mg, and 10 mg sublingual tablet.
What is Asenapine Maleate used for?
Asenapine Maleate is an atypical antipsychotic that is used to treat:
- Schizophrenia
- Bipolar I disorder
How does Asenapine Maleate work?
Asenapine Maleate is an atypical antipsychotic. It affects dopamine and serotonin activity in your brain, which can help regulate your thoughts, mood, and behaviors.
How do I take Asenapine Maleate?
Asenapine Maleate is dosed as follows:
Schizophrenia
- The usual dose is 5 mg under the tongue twice daily, with a maximum dose of 10 mg twice daily
Bipolar disorder
- Adults: The typical dose is 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 and teens aged 10 to 17 years: The typical dose is 2.5 mg to 10 mg under the tongue twice daily, with a maximum dose of 10 mg twice daily
Is it safe for me to take Asenapine Maleate?
Asenapine Maleate is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication in the following:
- Severe hepatic impairment (Child-Pugh C).
- Known hypersensitivity to Asenapine Maleate or to any components in the formulation
Asenapine Maleate Common Side Effects
Common side effects of Asenapine Maleate:
- Trouble sleeping
- Sleepiness
- Movement problems
- Restlessness (not being able to sit still)
- Dizziness
- Constipation
- Vomiting
- Mouth numbness
Asenapine Maleate Serious Side Effects
Serious side effects are rare with Asenapine Maleate. Contact your healthcare provider immediately if you experience any of the following.
- Neuroleptic malignant syndrome: high fever, sweating, confusion, stiffness, changing blood pressure
- Changes in heartbeat
- Suicidal thoughts or actions
- Seizures
Effects of other drugs, drug classes and over-the-counter products on Asenapine Maleate
The following medications may interact with Asenapine Maleate:
- Antihypertensive Drugs: Asenapine Maleate may cause hypotension
- Paroxetine (CYP2D6 substrate and inhibitor): Reduce paroxetine by half when used in combination with Asenapine Maleate
Who makes Asenapine Maleate?
Various FDA-approved generic manufacturers
Is Asenapine Maleate safe in pregnancy?
Neonates exposed to antipsychotic drugs such as Asenapine Maleate during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. Asenapine Maleate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Asenapine Maleate during pregnancy. For more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961 2388 or visit women’s health













