Two medicines, side by side
Asenapine vs lurasidone
Asenapine and lurasidone are both labeled for bipolar disorder and schizophrenia. Drugs@FDA records approvals of asenapine since 2009 and of lurasidone since 2010. Pharmacies paid $2.63 per tablet (Asenapine 10 mg tablet sl) and $0.142 per lurasidone HCl 20 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. How each works, in its label's words: Asenapine, “The mechanism of action of asenapine, in schizophrenia and bipolar I disorder, is unknown.”; Lurasidone, “The mechanism of action of lurasidone in the treatment of schizophrenia and bipolar depression is unclear.”
Check it at the source: the asenapine FDA label on DailyMed (effective January 31, 2025); the lurasidone FDA label on DailyMed (effective January 31, 2025).
Highlights of the asenapine record
Asenapine (Saphris) · label of January 31, 2025
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. SAPHRIS ® (asenapine) is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1, 5.2 )]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning.
Used for
From the label: indicationsAN D USAGE SAPHRIS is indicated for: Schizophrenia in adults [see Clinical Studies ( 14.1 )] Bipolar I disorder [see Clinical Studies ( 14.2 )] • Acute monotherapy 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 SAPHRIS is an atypical antipsychotic indicated for ( 1 ): […]
On the market
- Earliest approval on file
- August 13, 2009
- Generic labelers
- 5 labelers
- Pharmacy cost
- $2.63 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 3
Highlights of the lurasidone record
Lurasidone (Latuda) · label of January 31, 2025
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LATUDA is not approved for the treatment of patients with dementia-related psychosis ( 5.1 ).
Used for
From the label: indicationsLATUDA is indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies ( 14.1 )]. Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2 )]. […]
On the market
- Earliest approval on file
- October 28, 2010
- Generic labelers
- 28 labelers
- Pharmacy cost
- $0.142 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 2
Source: FDA drug labels via openFDA (Asenapine label of January 31, 2025, Lurasidone label of January 31, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do asenapine and lurasidone differ on the record?
How each works, in its label's words: Asenapine, “The mechanism of action of asenapine, in schizophrenia and bipolar I disorder, is unknown.”; Lurasidone, “The mechanism of action of lurasidone in the treatment of schizophrenia and bipolar depression is unclear.”
Both are in FDA's class atypical antipsychotics.
Both labels carry a boxed warning; the records quote them.
Generics: asenapine since 2020; lurasidone since 2019 (Drugs@FDA).
| Asenapine | Lurasidone | |
|---|---|---|
| Labeled for | Schizophrenia, Bipolar disorder | Schizophrenia, Bipolar disorder, Depression |
| Pharmacologic class | Atypical Antipsychotic | Atypical Antipsychotic |
| How it works (label) | The mechanism of action of asenapine, in schizophrenia and bipolar I disorder, is unknown. | The mechanism of action of lurasidone in the treatment of schizophrenia and bipolar depression is unclear. |
| Half-life (label) | Following an initial more rapid distribution phase, the mean terminal half-life is approximately 24 hrs. | n/a |
| Earliest approval on file (Drugs@FDA) | August 13, 2009 | October 28, 2010 |
| First generic approved | December 10, 2020 | January 3, 2019 |
| Generic labelers (NDC) | 5 labelers | 28 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $2.63 per tablet (Asenapine 10 mg tablet sl) | $0.142 per tablet (Lurasidone HCl 20 mg tablet) |
| 12-month price change | +5% | -28% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 3 | 2 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 8,667 | 20,803 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to asenapine
- every medicine labeled for the same conditions