Asenapine: Uses, Interactions and Safety

Uses

Asenapine is an atypical antipsychotic given as a sublingual tablet. Turkish Sycrest labeling includes adult schizophrenia and acute manic or mixed episodes of bipolar I disorder, alone or with lithium or valproate. The current US Saphris label additionally includes adult bipolar maintenance and selected acute bipolar use at ages ten to seventeen; these approvals should not be transferred to another country’s label.

Administration

Place the tablet under the tongue and let it dissolve completely. Do not split, crush, chew or swallow it. Avoid food and drink for ten minutes afterwards. Turkish instructions say to take asenapine last when other oral medicines are taken together. Transdermal asenapine has different instructions and is outside this summary.

Safety

Monitoring may include weight, blood glucose, lipids, blood pressure and movement symptoms. Severe liver impairment is contraindicated in the current US label; the older Turkish document describes it as not recommended. Serious allergic reactions have occurred, including after an initial dose. Antipsychotics increase mortality in older adults with dementia-related psychosis, for which Saphris is not approved.

Interactions

Fluvoxamine can raise asenapine exposure and may require a clinician-directed adjustment. Asenapine can increase paroxetine exposure; the US label recommends reducing the paroxetine dose. Antihypertensives can increase hypotension. Alcohol and other centrally acting medicines increase impairment. Avoid combinations with significant QT-prolonging drugs, including sotalol, chlorpromazine or ziprasidone. Lithium or valproate may be intentional bipolar co-treatment and is not a contraindicated pairing.

Pregnancy and breastfeeding

Pregnancy requires discussion of treatment needs and possible newborn movement or withdrawal effects after late exposure. Breastfeeding advice differs between labels and should be discussed before treatment.

Adverse effects

Common effects include sleepiness, dizziness, akathisia, oral numbness and weight gain. Seek urgent help for breathing difficulty, facial or tongue swelling, fainting, or fever with stiff muscles and confusion.

Sources

• SAPHRIS (asenapine) sublingual tablets – US prescribing information (Revised 1/2025; SPL effective 2025-01-31)
• Turkish product information: SYCREST 5 mg sublingual tablets