Overview
Caplyta is approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia and for use as an adjunctive therapy with antidepressants for major depressive disorder (MDD) in adults. It is also approved as monotherapy and as adjunctive therapy with lithium or valproate for depressive episodes associated with bipolar 1 or 2 disorder (bipolar depression) in adults. Caplyta is not approved for use in children. Caplyta is also known by its drug name, lumateperone.

Caplyta is an antipsychotic medication. Scientists believe it works by affecting levels of neurotransmitters (chemical messengers in the brain) such as dopamine and serotonin, which play roles in mood, thought, and behavior.

How do I take it?
Prescribing information states that Caplyta is taken by mouth once daily, with or without food. For most adults, the recommended dose is taken once daily. For people with moderate or severe liver problems, a lower dose is recommended. Caplyta should be taken exactly as prescribed by a healthcare provider.

Side effects
Common side effects of Caplyta include dizziness, dry mouth, somnolence (sleepiness or drowsiness), nausea, fatigue, and diarrhea in people with MDD. In people with bipolar depression, common side effects include somnolence, sedation, dizziness, nausea, and dry mouth. In people with schizophrenia, common side effects include somnolence and dry mouth.

Rare but serious side effects may include increased risk of death in elderly people with dementia-related psychosis, suicidal thoughts or behaviors (especially in young adults), neuroleptic malignant syndrome (a life-threatening nervous system disorder), tardive dyskinesia (involuntary movements), metabolic changes such as hyperglycemia (high blood sugar), dyslipidemia (abnormal cholesterol or fat levels in the blood), and weight gain, blood problems such as leukopenia, neutropenia, and agranulocytosis (low white blood cell counts), orthostatic hypotension (a sudden drop in blood pressure when standing), seizures, and cognitive or motor impairment that may affect the ability to drive or operate machinery.

Note: If you or someone you know needs help, you can contact the 988 Suicide & Crisis Lifeline by calling or texting 988 or chatting online.

For more information about this treatment, visit:

Caplyta (Lumateperone) Capsules, for Oral Use — Intra-Cellular Therapies