Saphris (Asenapine Sublingual Tablets) Patient Information: Side Effects and Drug Images at RxList

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May 27, 2012

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Schizophrenia facts

Schizophrenia is a chronic, severe, debilitating mental illness that affects about 1% of the population, more than 2 million people in the United States alone.
With the sudden onset of severe psychotic symptoms, the individual is said to be experiencing acute schizophrenia. Psychotic means out of touch with reality or unable to separate real from unreal experiences.
There is no known single cause of schizophrenia. As discussed later, it appears that genetic factors produce a vulnerability to schizophrenia, with environmental factors contributing to different degrees in different individuals.
There are a number of various treatments for schizophrenia. Given the complexity of schizophrenia, the major questions about this disorder (its cause or causes, prevention, and treatment) are unlikely to be resolved in the near future. The public should beware of those offering "t...

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SAPHRIS®
(asenapine) Sublingual Tablets

WARNING

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. SAPHRIS® (asenapine) is not approved for the treatment of patients with dementia-related psychosis [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

SAPHRIS is a psychotropic agent that is available for sublingual administration. Asenapine belongs to the class dibenzo-oxepino pyrroles. The chemical designation is (3aRS,12bRS)-5-Chloro-2-methyl2,3,3a,12b-tetrahydro-1Hdibenzo[2,3:6,7]oxepino[4,5-c]pyrrole (2Z)-2-butenedioate (1:1). Its molecular formula is C₁₇H₁₆ClNO•C₄H₄O₄ and its molecular weight is 401.84 (free base: 285.8). The chemical structure is:

SAPHRIS® (asenapine) Structural Formula Illustration

Asenapine is a white to off-white powder.

SAPHRIS is supplied for sublingual administration in tablets containing 5-mg or 10-mg asenapine; inactive ingredients include gelatin and mannitol.

SAPHRIS, black cherry flavor, is supplied for sublingual administration in tablets containing 5-mg or 10-mg asenapine; inactive ingredients include gelatin, mannitol, sucralose, and black cherry flavor.

Last reviewed on RxList: 10/21/2011
This monograph has been modified to include the generic and brand name in many instances.