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Saphris is the brand name for asenapine and is available as a sublingual tablet.

Saphris is available as a 2.5 mg, 5 mg, and 10 mg sublingual tablet.

Saphris is an atypical antipsychotic that is used to treat:

• Schizophrenia
• Bipolar I disorder

Saphris is an atypical antipsychotic. It affects dopamine and serotonin activity in your brain, which can help regulate your thoughts, mood, and behaviors.

Saphris 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

Saphris 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 Saphris or to any components in the formulation

Common side effects of Saphris:

• Trouble sleeping
• Sleepiness
• Movement problems
• Restlessness (not being able to sit still)
• Dizziness
• Constipation
• Vomiting
• Mouth numbness

Serious side effects are rare with Saphris. 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

The following medications may interact with Saphris:

• Antihypertensive Drugs: Saphris may cause hypotension
• Paroxetine (CYP2D6 substrate and inhibitor): Reduce paroxetine by half when used in combination with Saphris

Allergan

Neonates exposed to antipsychotic drugs such as Saphris during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. Saphris 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 Saphris during pregnancy. For more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961­ 2388 or visit women’s health

• Asenapine Maleate