SUMMARY

• There were no reports of serotonin syndrome adverse events in CAPLYTA clinical trials across all indications (adjunctive major depressive disorder [MDD], bipolar I or II disorder, and schizophrenia).

PRODUCT LABELING

Clinically Important Drug Interactions with CAPLYTA

Increased monitoring for serotonin reuptake inhibitors (SRI)-associated adverse reactions is recommended.¹ 

Although no clinically significant drug interactions with adjunctive selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors (SSRI/SNRIs) in MDD were observed in CAPLYTA clinical trials, CAPLYTA’s moderate serotonin transporter (SERT) activity may increase the risk of SRI-associated adverse reactions (e.g. serotonin syndrome, hyponatremia).¹ 

clinical data

There were no reports of serotonin syndrome adverse events in CAPLYTA clinical trials across all indications (adjunctive major depressive disorder, bipolar I or II disorder, and schizophrenia).

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 28 October 2025.