SUMMARY  

• INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS: Elderly patients with dementia-related psychosis treated with antipsychotic drugs and are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.¹ 
• Controlled clinical studies of CAPLYTA for the treatment of schizophrenia and as adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) did not include any patients aged 65 or older to determine whether or not they respond differently from younger adult patients.¹ 
• Among the CAPLYTA-treated patients in clinical studies for the treatment of depressive episodes associated with bipolar depression, 20 (6%) were 65 to 74 years of age, and none were 75 years of age or older. These clinical studies did not include sufficient numbers of patients aged 65 years of age or older to determine whether or not they respond differently from younger adult patients.¹ 
• Elderly patients with dementia-related psychosis treated with antipsychotics have an increased risk of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack) including fatalities, compared to those treated with placebo.¹ 
• Antipsychotic drugs increase the risk of tardive dyskinesia and this risk appears to be highest among the elderly, particularly elderly women.¹ 
• The use of serotonin reuptake inhibitors (SRIs) has been associated with clinically significant hyponatremia in geriatric patients, who may be at greater risk for this adverse reaction. The concomitant use of CAPLYTA with an SRI may increase this risk.¹ 

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) conducted on 18 September 2025 did not identify any relevant citations pertaining to this topic.