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Asenapine (Saphris®): Basic Information

This article was last reviewed/ updated on January 17, 2023.


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


FDA-approved indications

1. Schizophrenia in adults

2. Bipolar I disorder

  • Acute monotherapy treatment of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age
  • Adjunctive treatment to lithium or valproate in adults
  • Maintenance monotherapy treatment in adults

Pharmacokinetics

– Asenapine is metabolized by UGT1A4 (glucuronidation) and cytochrome P450 1A2 (oxidation).

– Its mean half-life is approximately 24 hours.


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 (acute and maintenance 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


Important! Please refer to the full Prescribing Information (see the link below) before prescribing this medication.


Related Pages

Second-generation (“atypical”) antipsychotics (List)

Second-generation antipsychotics: Dose equivalents

The patient who “demands” TWO antipsychotics

What should I be doing to monitor patients who are on an antipsychotic?

Main menu: Treatments


References

Asenapine Prescribing Information


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