Asenapine, sold under the brand name Saphris among others, is an atypical antipsychotic medication used to treat schizophrenia and acute mania associated with bipolar disorder.It was chemically derived via altering the chemical structure of the tetracyclic (atypical) antidepressant, mianserin.It was initially approved in the United States in 2009 and approved as a generic medication in 2020. Medical uses
Asenapine has been approved by the FDA for the acute treatment of adults with schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults. In Australia asenapines approved (and also listed on the PBS) indications include the following:
Schizophrenia
Treatment, for up to 6 months, of an episode of acute mania or mixed episodes associated with bipolar I disorder
Maintenance treatment, as monotherapy, of bipolar I disorderIn the European Union and the United Kingdom, asenapine is only licensed for use as a treatment for acute mania in bipolar I disorder.Asenapine is absorbed readily if administered sublingually, asenapine is poorly absorbed when swallowed. A transdermal formulation of asenapine was approved in the United States in October 2019 under the brand name Secuado. Schizophrenia
A Cochrane systematic review found that while Asenapine has some preliminary evidence that it improves positive, negative, and depressive symptoms, it does not have enough research to merit a certain recommendation of Asenapine for the treatment of schizophrenia.
sinus tachycardia
Orthostatic hypotension
Hypotension
Swollen tongue
Dysphagia (difficulty swallowing)
Glossodynia
Oral paraesthesiaRare (0.01-0.1% incidence) adverse effects include:

Neuroleptic malignant syndrome (Combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness, and sudden change in blood pressure and heart rate)
Tardive dyskinesia
Speech disturbance
Rhabdomyolysis
Angioedema
Blood dyscrasias such as agranulocytosis, leukopenia and neutropenia
Accommodation disorder
Pulmonary embolism
Gynaecomastia
GalactorrhoeaUnknown incidence adverse effects

Allergic reaction
Restless legs syndrome
Nausea
Oral mucosal lesions (ulcerations, blistering and inflammation)
Salivary hypersecretion
HyperprolactinaemiaAsenapine seems to have a relatively low weight gain liability for an atypical antipsychotic (which are notorious for their metabolic side effects) and a 2013 meta-analysis found significantly less weight gain (SMD [standard mean difference in weight gained in those on placebo vs. active drug]: 0.23; 95% CI: 0.07-0.39) than, paliperidone (SMD: 0.38; 95% CI: 0.27-0.48), risperidone (SMD: 0.42; 95% CI: 0.33-0.50), quetiapine (SMD: 0.43; 95% CI: 0.34-0.53), sertindole (SMD: 0.53; 95% CI: 0.38-0.68), chlorpromazine (SMD: 0.55; 95% CI: 0.34-0.76), iloperidone (SMD: 0.62; 95% CI: 0.49-0.74), clozapine (SMD: 0.65; 95% CI: 0.31-0.99), zotepine (SMD: 0.71; 95% CI: 0.47-0.96) and olanzapine (SMD: 0.74; 95% CI: 0.67-0.81) and approximately (that is, no statistically significant difference at the p=0.05 level) as much as weight gain as aripiprazole (SMD: 0.17; 95% CI: 0.05-0.28), lurasidone (SMD: 0.10; 95% CI: –0.02-0.21), amisulpride (SMD: 0.20; 95% CI: 0.05-0.35), haloperidol (SMD: 0.09; 95% CI: 0.00-0.17) and ziprasidone (SMD: 0.10; 95% CI: –0.02-0.22). Its potential for elevating plasma prolactin levels seems relatively limited too according to this meta-analysis.