Safety & Tolerability

CAPLYTA demonstrated safety in 2,664 adult patients with schizophrenia and bipolar depression1

Most common adverse reactions in 4- to 6-week schizophrenia inpatient trials (morning dosing)1,3*

Adverse reactionCAPLYTA 42 mg (n=406)Placebo (n=412)
Dry mouth6%2%

Incidence of at least 5% of subjects exposed to CAPLYTA and greater than twice the rate of placebo.1

  • Somnolence with CAPLYTA was predominantly mild3
  • There was no single adverse reaction leading to discontinuation that occurred at a rate of >2% in
    CAPLYTA-treated patients1

In 4- to 6-week trials, patients on CAPLYTA experienced metabolic, EPS, prolactin, and weight changes similar to placebo1,3

Antipsychotic drugs have been reported to cause:

  • Hyperglycemia, diabetes, dyslipidemia, and weight gain. Blood glucose, weight, and lipids should be monitored periodically during long-term treatment.
  • Tardive dyskinesia (TD), which may increase as the duration of treatment and cumulative dose increases, and can develop after brief treatment periods or after discontinuation. See additional Important Safety Information below.

Frequently asked questions about safety

References: 1. CAPLYTA full prescribing information, 2022. 2. Rowe W, Edwards JB, Durgam S et al. Somnolence and sedation with lumateperone (ITI-007) treatment: a comparison of morning and evening administration. Poster presented at: College of Psychiatric and Neurologic Pharmacists 2020 Virtual Conference; April 27-May 1, 2020; Virtual.