SUMMARY  

Most Common Adverse Reactions¹ 

• The most common adverse reactions (incidence of at least 5% of CAPLYTA-treated patients and greater than twice the rate of placebo-treated patients) in clinical trials of adult patients with schizophrenia were somnolence/sedation and dry mouth.
• The most common adverse reactions (incidence of at least 5% of CAPLYTA-treated patients and greater than twice the rate in placebo-treated patients) in clinical trials of adult patients with bipolar depression were somnolence/sedation, dizziness, nausea, and dry mouth.
• The most common adverse reactions (incidence of at least 5% of patients treated with CAPLYTA and background antidepressant therapy [ADT] and greater than twice the incidence in patients treated with placebo and background ADT) in clinical trials of adult patients with major depressive disorder (MDD) were dizziness, dry mouth, somnolence/sedation, nausea, fatigue, and diarrhea.  

Discontinuation Due to Adverse Reactions¹  

• Based on pooled short-term (4- to 6-week) placebo-controlled studies in adult patients with schizophrenia in which CAPLYTA was administered at a dosage of 42 mg once daily, there was no single adverse reaction that led to discontinuation that occurred at a rate of >2% in CAPLYTA-treated patients.
• Based on the 6-week, placebo-controlled monotherapy and adjunctive therapy bipolar depression studies in adult patients treated with CAPLYTA administered at a daily dose of 42 mg, there was no single adverse reaction leading to discontinuation that occurred at a rate of >2% in CAPLYTA-treated patients.
• Based on pooled short-term (6-week), placebo-controlled adjunctive therapy MDD studies in adult patients treated with CAPLYTA 42 mg orally once daily and background ADT or placebo and background ADT, there was no single adverse reaction leading to discontinuation that occurred at an incidence of >2% in patients treated with CAPLYTA and background ADT.

PRODUCT LABELING

Please refer to the following sections of the full Prescribing Information that are relevant to your inquiry: BOXED WARNING, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS.¹ 

Boxed Warning¹ 

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.
• Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients.

Contraindications¹ 

CAPLYTA is contraindicated in patients with history of hypersensitivity reaction to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.

Warning and Precautions¹ 

Please refer to the full Prescribing Information for detailed information regarding Warnings and Precautions for CAPLYTA.

• Increased Mortality in Elderly Patients with Dementia-Related Psychosis
• Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients
• Cerebrovascular Adverse Reactions, including Stroke, in Elderly Patients with Dementia-Related Psychosis
• Neuroleptic Malignant Syndrome
• Tardive Dyskinesia
• Metabolic Changes
• Leukopenia, Neutropenia, and Agranulocytosis
• Orthostatic Hypotension and Syncope
• Falls
• Seizures
• Potential for Cognitive and Motor Impairment
• Body Temperature Dysregulation
• Dysphagia

Adverse Reactions¹

Please refer to the ADVERSE REACTIONS section of the full Prescribing Information for additional information.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) conducted on 28 October 2025 did not identify any relevant citations pertaining to this topic.