Caplyta is a brand-name prescription medication containing the active ingredient lumateperone. Currently, no generic version of the medication is available.

An important note about Caplyta for older adults

The Food and Drug Administration (FDA) does not approve Caplyta for people with dementia-related psychosis.

Older adults with dementia-related psychosis receiving treatment with antipsychotic medications are at an increased risk of death.

Medicare Part D drug plans may cover this medication if a doctor or another healthcare professional prescribes it.

Private insurance companies administer Part D prescription drug plans on Medicare’s behalf, so drug costs and drug availability can vary by plan type and plan provider.

If you have schizophrenia or bipolar-related depression, a doctor or another healthcare professional may prescribe Caplyta (lumateperone), and when medically necessary, Medicare may cover some of or all the costs.

Part D drug plans have three coverage stages, including the:

  • deductible stage
  • initial coverage stage
  • catastrophic coverage stage

The deductible stage

Not all Part D prescription drug plans have a deductible, but if yours does, you will join at this stage.

Once you have paid the plan deductible in full, the plan will begin paying its share of eligible costs.

Initial coverage stage

During this stage, you’ll pay a 25% coinsurance toward the cost of Caplyta (lumateperone).

In 2025, you will continue paying the 25% coinsurance until you’ve paid a total of $2,000. In 2026, this is expected to increase to $2,100.

Catastrophic coverage stage

During this stage, you will pay no further costs toward your prescription medications for the remaining calendar year.

You will receive an explanation of benefits (EOB) the month after your pharmacy bills your plan provider. The EOB will detail the following:

  • The prescriptions you’ve filled
  • The total amount the plan has paid
  • The total amount you’ve paid
  • The amount others have paid, such as another insurer (if applicable)
  • The coverage stage you’re at
  • What the plan has counted toward your total out-of-pocket expenses
  • The total amount the pharmacy has charged for your medications

Caplyta is the brand-name medication. Its active ingredient is lumateperone. Currently, no generic version of this medication is available, although one may become available in the future.

The FDA approved this medication for the treatment of schizophrenia and depression associated with bipolar I or bipolar II disorder.

Boxed warnings for Caplyta (lumateperone)

There are boxed warnings for this medication, which is the most serious warning from the FDA.

Boxed warnings apply to medications that have serious risks for the person taking them. The FDA decides which medications need these important warnings.

The FDA advises that Caplyta:

  • is not approved for older adults with dementia-related psychosis.
  • is not confirmed to be safe or effective in children.
  • may increase the risk of suicidal thoughts and behaviors.

How Caplyta (lumateperone) works

Caplyta (lumateperone) is in the drug class called atypical antipsychotics.

It interacts with dopamine, serotonin, and the excitatory amino acid system. However, the mechanism of action, or how it works, has not yet been confirmed.