Asenapine (US brand name Saphris®) is a second-generation (“atypical”) antipsychotic.

FDA-approved indications

1. Schizophrenia
2. Acute treatment of manic and mixed episodes associated with bipolar I disorder (monotherapy)
3. Acute treatment of manic and mixed episodes associated with bipolar I disorder (adjunctive to lithium or valproate)

Dosage

Schizophrenia – acute treatment in adults
Starting: 5 mg sublingually twice daily
Recommended: 5 mg sublingually twice daily
Maximum: 10 mg sublingually twice daily

Schizophrenia – maintenance treatment in adults
Starting: 5 mg sublingually twice daily
Recommended: 5–10 mg sublingually twice daily
Maximum: 10 mg sublingually twice daily

Bipolar mania – adults (monotherapy)
Starting: 10 mg sublingually twice daily
Recommended: 5–10 mg sublingually twice daily
Maximum: 10 mg sublingually twice daily

Bipolar mania – children 10 to 17 yrs (monotherapy)
Starting: 2.5 mg sublingually twice daily
Recommended: 2.5–10 mg sublingually twice daily
Maximum: 10 mg sublingually twice daily

Bipolar mania – adults (adjunct to lithium or valproate)
Starting: 5 mg sublingually twice daily
Recommended: 5–10 mg sublingually twice daily
Maximum: 10 mg sublingually twice daily

General Instructions

1. Sublingual tablets should not be swallowed.
2. Sublingual tablets should be placed under the tongue and left to dissolve completely.
3. Eating and drinking should be avoided for 10 minutes after administration.

Dosage forms and strengths

Sublingual tablets: 2.5 mg, 5 mg, and 10 mg