Uses of Saphris (Asenapine)
Saphris (asenapine) is primarily indicated for the treatment of bipolar I disorder (manic or mixed episodes) in adults and children aged 10-17 years, and for the treatment of schizophrenia in adults.
Primary Indications
Bipolar I Disorder
- Adult patients: FDA-approved for acute treatment of manic and mixed episodes, as both monotherapy and adjunctive therapy with lithium or valproate 1
- Pediatric patients (10-17 years): FDA-approved as monotherapy for acute treatment of manic and mixed episodes at a recommended dose of 2.5-10 mg twice daily 2
Schizophrenia
- Adult patients: FDA-approved for acute treatment 3
- Not approved for pediatric patients with schizophrenia despite being studied in this population 2
Efficacy Profile
Bipolar Disorder
- Demonstrates significant improvement in Young Mania Rating Scale (YMRS) scores compared to placebo, with effects observable after just 2 days of treatment 1
- Shows efficacy in:
- Improving Clinical Global Impression for Bipolar Disorder (CGI-BP) mania severity scores
- Achieving higher response and remission rates compared to placebo
- Maintaining efficacy over extended treatment periods (up to 52 weeks) 1
Adjunctive Therapy
- More effective than placebo when used as adjunctive therapy with lithium or valproate over a 12-week period 1
Administration Considerations
- Formulation: Sublingual tablets (5 mg or 10 mg) that dissolve rapidly 1
- Administration requirements:
- Must be taken sublingually
- Food and water should be avoided for 10 minutes after administration
- Twice-daily dosing schedule required 3
- Bioavailability: Very low if swallowed instead of taken sublingually 3
Safety Profile
Common Adverse Effects
- Somnolence and sedation (most common)
- Dizziness
- Extrapyramidal symptoms (excluding akathisia)
- Weight gain 1
Metabolic Profile
- Minimal effects on plasma glucose, lipid, and prolactin levels in both short and long-term treatment 1
- Lower risk of metabolic abnormalities compared to some other antipsychotics, potentially valuable for patients at high risk for metabolic disorders 1
Special Populations
- Pediatric patients experience similar pharmacokinetics to adults, so adult dosages don't require adjustment for pediatric use 2
- Common adverse events in pediatric patients mirror those in adults: sedation, somnolence, and weight gain 2
Clinical Considerations and Limitations
- No demonstrated efficacy advantage over other antipsychotic agents 3
- Potential barriers to compliance include:
- Twice-daily dosing requirement
- Need to avoid food/liquids for 10 minutes after administration
- Requirement for proper sublingual administration 3
Prescribing Context
When selecting asenapine for a patient, consider its place among other second-generation antipsychotics based on:
- Patient's diagnosis and symptom profile
- Patient's ability to adhere to sublingual administration requirements
- Patient's metabolic risk factors
- Prior response to other antipsychotic medications
Asenapine represents a valuable option particularly for patients with bipolar I disorder who may benefit from its favorable metabolic profile compared to some other antipsychotic medications.