What Is Caplyta?

Caplyta (lumateperone) is an atypical antipsychotic medication manufactured by Intra-Cellular Therapies, now part of Johnson & Johnson. It is FDA-approved for:

• Schizophrenia in adults
• Bipolar depression (depressive episodes associated with bipolar I or II disorder) as monotherapy or adjunctive therapy with lithium or valproate in adults
• Major depressive disorder (MDD) as adjunctive therapy with antidepressants in adults (approved November 2025)

Caplyta is taken as a once-daily oral capsule at a standard dose of 42 mg. No dose titration is needed. It can be taken with or without food.

How does Caplyta work?

Caplyta (lumateperone) is a multitarget agent that modulates three major neurotransmitter systems in the brain:

• Serotonin — acts as a 5-HT2A receptor antagonist
• Dopamine — works as a partial agonist at presynaptic D2 receptors and an antagonist at postsynaptic D2 receptors
• Glutamate — modulates GluN2B receptors

Caplyta also has moderate serotonin transporter (SERT) inhibition activity, which may contribute to its antidepressant effects. This unique mechanism across serotonin, dopamine, and glutamate pathways distinguishes it from older antipsychotics and may explain its favorable tolerability profile with less weight gain and metabolic effects than many other atypical antipsychotics.

Take one capsule by mouth once daily. Swallow the capsule whole — do not crush, chew, or open it.

What doses are available for Caplyta?

• 10.5 mg capsules — for patients on strong CYP3A4 inhibitors
• 21 mg capsules — for patients on moderate CYP3A4 inhibitors or with hepatic impairment
• 42 mg capsules — standard dose for most patients

How hard is it to find Caplyta in stock?

Caplyta scores a 55 out of 100 on our findability scale, meaning it's moderately difficult to find and may require some effort to locate. Caplyta is not currently listed on the FDA or ASHP drug shortage databases, and there are no active supply disruptions.

However, as a brand-only specialty medication manufactured solely by Intra-Cellular Therapies (now part of Johnson & Johnson), not every pharmacy carries it in stock. Caplyta's expanding indications — now covering schizophrenia, bipolar depression, and adjunctive MDD treatment — have increased demand, which can lead to temporary stock-outs at individual pharmacies.

Use Medfinder to quickly locate which pharmacies near you have Caplyta in stock.

Who Can Prescribe Caplyta?

Caplyta is typically prescribed by:

• Psychiatrists — the most common prescribers for schizophrenia, bipolar depression, and treatment-resistant depression
• Primary care physicians — may prescribe for adjunctive MDD treatment
• Neurologists — less commonly, for patients with overlapping neuropsychiatric conditions

Telehealth consultations are available for Caplyta prescriptions, making it accessible for ongoing management. Initial evaluations typically require a comprehensive psychiatric assessment.

Is Caplyta a controlled substance?

No. Caplyta is not a controlled substance and does not have a DEA schedule. It is a prescription-only medication but does not carry the restrictions associated with controlled substances.

However, Caplyta carries a boxed warning regarding increased risk of death in elderly patients with dementia-related psychosis (it is not approved for this use) and increased risk of suicidal thoughts and behaviors in pediatric and young adult patients when used for depression. Patients should be monitored for clinical worsening and emergence of suicidal thoughts.

Common Side Effects of Caplyta

The most frequently reported side effects include:

• Somnolence/sedation (12–24%)
• Dizziness (up to 17%)
• Dry mouth (up to 13%)
• Nausea (up to 9%)
• Fatigue (up to 8%)
• Diarrhea (up to 5%)
• Decreased appetite
• Vomiting

Serious side effects (seek medical attention immediately):

• Neuroleptic malignant syndrome (NMS) — high fever, muscle rigidity, confusion
• Tardive dyskinesia — uncontrollable movements of the face or body
• Metabolic changes — hyperglycemia, dyslipidemia, weight gain
• Orthostatic hypotension and syncope (fainting)
• Leukopenia, neutropenia, agranulocytosis
• Seizures
• Serotonin syndrome (when combined with serotonergic drugs)

Alternative Medications to Caplyta

If Caplyta is not right for you, several other atypical antipsychotics may be considered:

• Latuda (lurasidone) — approved for schizophrenia and bipolar depression, with a generic available at significantly lower cost
• Vraylar (cariprazine) — approved for schizophrenia, bipolar depression, and bipolar mania
• Rexulti (brexpiprazole) — approved for schizophrenia and adjunctive MDD treatment
• Seroquel (quetiapine) — approved for schizophrenia, bipolar depression, and adjunctive MDD, with a generic available

Generic alternatives like lurasidone and quetiapine can cost as little as $20–$80 per month, compared to Caplyta's $1,650–$1,800 cash price. Discuss with your psychiatrist which option balances efficacy, side effects, and cost for your situation.

Drug Interactions with Caplyta

Caplyta can interact with several other medications. Inform your doctor about all medications you are taking:

• Strong CYP3A4 inhibitors (ketoconazole, clarithromycin, itraconazole) — requires dose reduction to 10.5 mg daily
• Moderate CYP3A4 inhibitors (diltiazem, erythromycin, fluconazole) — requires dose reduction to 21 mg daily
• CYP3A4 inducers (carbamazepine, rifampin, St. John's wort) — avoid concomitant use
• Serotonergic drugs (SSRIs, SNRIs) — increased risk of serotonin syndrome and hyponatremia
• Other CNS depressants — additive sedation
• Antihypertensives — additive hypotensive effects
• Anticholinergic drugs — additive effects

Food interaction: Avoid grapefruit and grapefruit juice, which can increase Caplyta levels by inhibiting CYP3A4.

Final Thoughts on Caplyta

Caplyta is a newer atypical antipsychotic with a unique mechanism of action spanning serotonin, dopamine, and glutamate systems. Its expanding FDA-approved indications — now including schizophrenia, bipolar depression, and adjunctive MDD treatment — make it an increasingly versatile option in psychiatry. Many clinicians favor it for its favorable side effect profile, with less weight gain and metabolic disruption than older antipsychotics.

The biggest challenge with Caplyta is cost. At $1,650–$1,800 per month without insurance and no generic available, it's a significant expense. However, the Caplyta Savings Card can bring the cost down to as little as $15 per fill for commercially insured patients. Uninsured patients should explore the Johnson & Johnson Patient Assistance Program for potential no-cost access.

Use Medfinder to locate pharmacies near you that have Caplyta in stock, and check coupon platforms like GoodRx and SingleCare for additional savings.