Saphris (Asenapine) for Schizophrenia

Saphris (asenapine) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for treating adults with schizophrenia.

How Saphris Works and How It’s Taken

Saphris is a type of antipsychotic medicine that works by affecting chemicals in the brain called neurotransmitters, such as dopamine and serotonin. The exact way it works in schizophrenia is not fully known.

Doctors prescribe Saphris to adults with schizophrenia.

Saphris comes as a tablet that you place under your tongue. The tablet melts quickly in your mouth within a few seconds. Do not swallow it. Let it fully dissolve, and wait 10 minutes before eating or drinking.

Typical Dosing for Schizophrenia

The recommended starting dose of Saphris for schizophrenia is 5 milligrams given twice daily.

For individuals who respond to treatment, the recommended maintenance dose is 5 milligrams to 10 milligrams given twice daily.

This information is based on the prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Saphris Side Effects

In clinical studies of adults taking Saphris for schizophrenia, the most common side effects that occurred in more than 5 percent of individuals, and more often than a placebo (inactive treatment), were:

Akathisia (restlessness with an urge to move)
Oral hypoesthesia (mouth numbness or tingling)
Somnolence (sleepiness)

Serious Side Effects and Warnings

Saphris can cause serious conditions that require immediate medical attention. These include:

Increased risk of death in older adults with dementia-related psychosis — Saphris is not approved for this use.
Stroke and transient ischemic attack (TIA, sometimes called a ministroke) — These can occur in older adults with dementia-related psychosis.
Neuroleptic malignant syndrome (NMS) — This rare, life-threatening reaction can cause very high fever, stiff muscles, confusion, and unstable blood pressure or heart rate.
Tardive dyskinesia — These uncontrolled movements may not go away.
Metabolic changes — These can include high blood sugar or diabetes, unhealthy cholesterol or triglycerides, and weight gain.
Severe allergic reactions (hypersensitivity) — These can include anaphylaxis and angioedema, which can cause trouble breathing, swelling of the face, tongue, or throat, and low blood pressure.
Orthostatic hypotension and fainting — A sudden drop in blood pressure when standing can cause dizziness or passing out.
Falls — These may happen due to sleepiness, low blood pressure, or problems with balance.
Low white blood cell counts — Leukopenia, neutropenia, or agranulocytosis can raise the risk of infection.
QT prolongation — This heart rhythm change can be dangerous.
High prolactin levels — These can cause breast milk production, missed periods, breast enlargement, or sexual problems.
Seizures — These can occur while taking Saphris.
Problems with thinking or movement — These can affect alertness and coordination.
Problems controlling body temperature — Overheating can occur.
Dysphagia (trouble swallowing) — This can raise the risk of choking or breathing food or liquid into the lungs.

Get medical help right away if you think you are having a serious reaction.

How To Save on Saphris

AbbVie, the manufacturer of Saphris, offers the myAbbVie Assist Program. Eligible individuals who are uninsured, receiving coverage through Medicare, or whose health insurance is not enough to cover the cost of their medicine may be eligible to receive free medicine.

To learn more, visit the myAbbVie Assist available programs page.

What To Know Before Taking Saphris

Tell your doctor if you have any allergies to asenapine or have ever had an allergic reaction to Saphris.

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, and supplements. Saphris can interact with other medications and cause side effects.

Do not take Saphris if you have severe liver problems (Child-Pugh C) or if you have had a serious allergic reaction to asenapine.

Be careful when doing tasks that need you to stay alert, like driving or using machines, until you know how Saphris affects you.

Avoid getting too hot, and make sure you drink enough fluids so you do not become dehydrated.

If you are pregnant, planning to become pregnant, or breastfeeding while taking Saphris, talk with your doctor about the risks and benefits. Saphris may cause fetal harm. Taking Saphris during the third trimester of pregnancy may cause symptoms in a newborn.

These symptoms can include muscle stiffness or unusual movements, and withdrawal symptoms after birth. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Saphris during pregnancy. Call 866-961-2388 or visit the National Pregnancy Registry for Psychiatric Medications.

Saphris is also FDA-approved to treat bipolar 1 disorder.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Saphris?

In short-term studies that lasted six weeks, adults taking Saphris 5 milligrams two times a day had greater improvement in schizophrenia symptoms than those taking a placebo. This was measured using a standard symptom score called the Positive and Negative Syndrome Scale (PANSS). In long-term maintenance treatment, Saphris helped delay the return of schizophrenia symptoms compared to a placebo.

Can Saphris cause dizziness or feeling sleepy in people taking it for schizophrenia?

Yes. In adults with schizophrenia, somnolence was reported in 15 percent of people taking 5 milligrams twice daily and 13 percent taking 10 milligrams twice daily, compared with 7 percent with a placebo. Dizziness was reported in 7 percent with 5 milligrams twice daily and 3 percent with 10 milligrams twice daily, compared with 4 percent with a placebo. Feeling sleepy was usually temporary, with the highest incidence during the first week of treatment.

Can Saphris cause akathisia or movement-related side effects in people taking it for schizophrenia?

Yes. In adults with schizophrenia, akathisia was reported in 4 percent of people taking 5 milligrams twice daily and 11 percent taking 10 milligrams twice daily, compared with 3 percent with a placebo. Other extrapyramidal symptoms, which are movement-related side effects other than akathisia, were reported in 9 percent with 5 milligrams twice daily and 12 percent with 10 milligrams twice daily, compared with 7 percent with a placebo.