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    DEA Class;  Rx

    Common Brand Names; Saphris, Secuado

    • Antipsychotcs, 2nd Generation; 
    Atypical antipsychotic; sublingual and transdermal forms
    Sublingual tablet is used for the treatment of schizophrenia in adults, manic or mixed episodes and maintenance treatment of bipolar I disorder in adults, and for acute mania in pediatric patients 10 years and older; transdermal system is used for schizophrenia in adults
    Appears to have low risk of QT prolongation; as with all antipsychotics, boxed warning for increased mortality risk in elderly patients with dementia-related psychosis

    Indicated for the treatment of schizophrenia.

    For the treatment of bipolar disorder (bipolar I disorder), including mania or mixed episodes.
    For the treatment of severe behavioral or psychological symptoms of dementia.

    Known hypersensitivity

    Severe hepatic impairment (Child-Pugh C)


    Somnolence (24%)

    Headache (12%)

    Dizziness (11%)

    Pediatric patients

    • Oral paraesthesia (27%)
    • Somnolence (49%)


    Extrapyramidal symptoms (EPS) other than akathisia (7%)

    Insomnia (6%)

    Weight gain (5%)

    Akathisia (4%)

    Anxiety (4%)

    Fatigue (4%)

    Oral hypoesthesia (4%)

    Dyspepsia (4%)

    Dry mouth (3%)

    Dysgeusia (3%)

    Arthralgia (3%)

    Toothache (3%)

    Depression (2%)

    Extremity pain (2%)

    Pediatric patients

    • Nausea (6%)
    • Abdominal pain (6%)
    • Fatigue (9%)
    • Increased weight (3%)
    • Hyperinsulinemia (2%)
    • Increased appetite (8%)
    • Headache (9%)
    • Dizziness (7%)
    • Dysgeusia (6%)
    • Akathisia (2%)
    • Insomnia (3%)
    • Suicidal ideation (3%)
    • Tachycardia (1%), Glossodynia (1%), Irritability (1%), Muscle pain (1%), Increased ALT (1%), Increased AST (1%), Dehydration (1%), Myalgia (1%), Parkinsonism (1%), Anger (1%), Dysmenorrhea (1%), Rash (1%), Nasal congestion (1%), Dyspnea (1%), Oropharyngeal pain (1%)

    Hyperglycemia (monitor patients with diabetes mellitus for worsening of glucose control); assess fasting plasma glucose before or soon after initiation of antipsychotic medication, and monitor periodically during long-term treatment

    Weight gain may occur; monitor weight at baseline and frequently thereafter; monitor weight in pediatric patients and assess against that expected for normal growth

    Hypotension and syncope, especially during initial dose titration and when increasing dose; orthostatic vital signs should be monitored in patients who are vulnerable to hypotension (elderly patients, patients with dehydration, hypovolemia, concomitant treatment with antihypertensive medications, patients with known cardiovascular disease (history of myocardial infarction or ischemic heart disease, heart failure, or conduction abnormalities), and patients with cerebrovascular disease; monitoring of orthostatic vital signs should be considered in such patients, and dose reduction considered if hypotension occurs

    Leukopenia, neutropenia, and agranulocytosis reported with use; perform a complete blood count (CBC) during first few months of therapy; in such patients, consider discontinuation of therapy at first sign of clinically significant decline in WBC in absence of other causative factors

    Concurrent use of CNS-acting drugs or alcohol may increase toxicity

    Pregnancy category: C

    Neonates exposed to antipsychotic drugs during 3rd trimester of pregnancy are at risk for EPS or withdrawal symptoms after delivery; these complications vary in severity, with some being self-limited and others requiring ICU unit support and prolonged hospitalization

    Lactation: Excretion in milk unknown; use with caution


    20 mg/day SL tablet; 7.6 mg/24 hours transdermally.


    20 mg/day SL tablet; 7.6 mg/24 hours transdermally.


    20 mg/day SL tablet. Safety and efficacy of the transdermal system have not been established.


    10 to 12 years: 20 mg/day SL tablet. Safety and efficacy of the transdermal system have not been established.
    Less than 10 years: Safety and efficacy have not been established.


    Safety and efficacy have not been established.


    sublingual tablet

    • 2.5mg
    • 5mg
    • 10mg

    transdermal system