Saphris (Asenapine) for Depression

Overview
Saphris is approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in adults and for the treatment of bipolar 1 disorder in both adults and children aged 10 to 17. For bipolar 1 disorder, it may be used as a monotherapy (standalone therapy) or as an adjunct (add-on) therapy with lithium or valproate. It is also approved for maintenance treatment in adults with bipolar 1 disorder. Saphris is also known by its drug name, asenapine.

Saphris is an atypical antipsychotic. It works by helping to balance certain natural chemicals in the brain, including dopamine and serotonin, which are involved in mood, behavior, and thinking. This balance may reduce symptoms of schizophrenia and bipolar 1 disorder, such as hallucinations, mood swings, and agitation.

How do I take it?
Prescribing information states that Saphris is taken as a sublingual tablet, which means it is placed under the tongue and allowed to dissolve completely. Dosing varies depending on a person’s age and diagnosis. It is usually taken twice daily. The tablet dissolves in seconds, and eating or drinking should be avoided for 10 minutes after taking it. Saphris should be taken exactly as prescribed by a healthcare provider.

Side effects
Common side effects of Saphris vary by condition:

Schizophrenia (adults) — Akathisia (a feeling of restlessness), oral hypoesthesia (numbness in the mouth), and somnolence (sleepiness).

Bipolar 1 disorder (adults, monotherapy) — Somnolence, oral hypoesthesia, dizziness, extrapyramidal symptoms (movement problems such as tremors or stiffness, not including akathisia), and akathisia.

Bipolar 1 disorder (children, monotherapy) — Somnolence, dizziness, dysgeusia (altered taste), oral paresthesia (tingling in the mouth), nausea, increased appetite, fatigue, and increased weight.

Bipolar 1 disorder (adults, adjunctive therapy) — Somnolence and oral hypoesthesia.

Rare but serious side effects may include neuroleptic malignant syndrome (a life-threatening reaction with high fever and muscle rigidity), tardive dyskinesia (involuntary movements, often of the face), hyperglycemia/diabetes mellitus (high blood sugar), dyslipidemia (abnormal cholesterol levels), significant weight gain, orthostatic hypotension (sudden drop in blood pressure when standing), leukopenia, neutropenia, and agranulocytosis (low white blood cell counts), QT prolongation (abnormal heart rhythm), seizures, and impaired cognitive or motor function (difficulty with thinking or moving). Older individuals with dementia-related psychosis are at increased risk of death and should not be treated with Saphris.

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Label: Saphris — Asenapine Maleate Tablet — DailyMed