lurasidone (Latuda)

How long the trials actually ran

The longest trial behind the lurasidone approval ran 6 weeks.

The gap between how long the trials ran and how long people actually take these medications is the single most important thing on this page. It is not evidence that longer use is unsafe or ineffective. It is evidence that longer use was not what got tested.

How many Americans take lurasidone

Survey-based federal estimates, published with a lag of about two years. They count prescriptions filled, not outcomes.

2,433,438

prescriptions in the United States (2021)

385,353

people filling them (2021)

Prescriptions are up 66% since 2014. Whatever you decide about lurasidone, you are deciding alongside about 385,353 other people this year.

Source: ClinCalc DrugStats (Medical Expenditure Panel Survey (MEPS), Agency for Healthcare Research and Quality), CC BY-SA 4.0, release 2026.08.

What people report to the FDA about lurasidone

20,803

reports mentioning lurasidone, all time

9,272

filed as serious (a report-level flag covering every drug and outcome in the report)

Source: FDA Adverse Event Reporting System (FAERS), via openFDA, data through 2026-07-30.

Known interactions, from the label

The FDA label’s interactions section, verbatim. A pharmacist checking your actual medication list beats any published list — including this one.

FDA label for lurasidone, effective August 27, 2026 — DailyMed.

Who pays for lurasidone

Two claims datasets and one survey, covering different populations with different instruments — they cannot be reconciled by arithmetic, and where their sum crowds the all-payer estimate, that is a finding about the estimates rather than a percentage.

Medicare Part D

124,110 beneficiaries filled 853,499 claims in 2024 — 38,814 aged 65 and over, and 85,296 under 65. The under-65 group is not a picture of ordinary working-age adults: Medicare before 65 means the disabled and dual-eligible population — among the sickest, highest-need people in the program — and reading their utilization as typical adult use would be a category error.

Medicaid

At least 1,109,001 prescriptions in 2024 — a floor, because 80 of 696 national data rows are suppressed for privacy and contribute zero. Medicaid covers more children than any insurer in the country and publishes no age split — how much of this number is pediatric use is not knowable from public data.

All payers (survey estimate)

The MEPS-based estimate above puts the whole country at 2,433,438 prescriptions and 385,353 people in 2021. Subtracting the public programs from it would produce a number for everyone else — and we do not print that number, because subtracting a survey from claims counts manufactures precision that does not exist.

The population nobody counts

The commercially insured working-age adult — statistically, the likeliest person to be reading this page — is the one population with no public per-drug count anywhere. Private claims data exists and is sold, but nothing a patient can check is published. For children the record is thinner still: no public source counts pediatric use of lurasidone specifically; the closest the public record comes is condition-level treatment rates for children, which we have traced for one condition in how childhood ADHD got counted.

Sources: Medicare Part D Prescribers — by Geography and Drug, data.cms.gov, National rows, data year 2024 (published with ~17-month lag). Medicaid State Drug Utilization Data 2024, data.medicaid.gov, national aggregate rows. Retrieved 2026-09-01.

The approval, step by step

1. Step 1

   What the approval was actually based on

   Which studies did the FDA rely on, how long did they run, and who was in them?

   The efficacy of LATUDA for the treatment of schizophrenia was established in five short-term (6-week), placebo-controlled studies in adult patients (mean age of 38.4 years, range 18-72) who met DSM-IV criteria for schizophrenia.

   FDA-approved labelling, 14 CLINICAL STUDIES — read the label on DailyMed

   Our reading

   Five trials, every one of them six weeks, for a diagnosis that is by definition lifelong. Two of the five included an active comparator arm — olanzapine or quetiapine XR — but the label states these were there to confirm the studies could detect an effect at all, not to compare the drugs, which is a distinction marketing routinely flattens. The bipolar-depression indication came later with its own trials. Lurasidone's practical selling point is a milder metabolic profile than olanzapine; that claim comes from comparisons made after approval, not from anything in this section.

2. Step 2

   The approval

   When was it approved, under what application, and by whose review?

   Approved

   October 28, 2010

   Application

   NDA200603

   Review

   STANDARD

   Original sponsor

   Sunovion

   Holds it now

   Sumitomo Pharma America

   Label submissions since

   28

   Source: openFDA Drugs@FDA, original application ORIG-1

3. Step 3

   What was added after it was on the market

   Which warnings arrived only after millions of people were already taking it?

   • Antipsychotics raise the risk of death in older people with dementia

     This is one of the clearest harm signals in psychiatric medicine, and it applies to a specific group: older adults with dementia-related psychosis. Pooling 17 placebo-controlled trials covering 5,106 patients over roughly 10 weeks, the risk of death was 1.6 to 1.7 times higher on an antipsychotic than on placebo — about 4.5% against 2.6%. Most deaths were cardiovascular or infectious, chiefly heart failure, sudden death and pneumonia.

     The FDA first applied this warning to the newer antipsychotics in 2005 and extended it to the older ones in 2008. No antipsychotic is approved for dementia-related psychosis.

     If this is being prescribed for an older relative with dementia, worth asking: what specific behaviour are we treating, what have we tried that is not a drug, what is the shortest time we can plan for, and when will we review stopping.

     RISPERDAL (risperidone) prescribing information — Boxed Warning: Increased Mortality in Elderly Patients with Dementia-Related Psychosis — U.S. Food and Drug Administration (approved labelling)

4. Step 4

   What independent research has found since

   What has been learned by people who were not selling it?

   We have not yet added independent post-approval research on lurasidone to the evidence library. Absence here means we have not covered it, not that none exists.

5. Step 5

   What still is not known

   Which questions you might reasonably have has nobody answered yet?

   • Six weeks per trial, for a lifelong diagnosis. What evidence covers year five?
   • The comparator arms were for assay sensitivity, not comparison — so which antipsychotic is actually better for this patient, and on what evidence?
   • The metabolic advantage that drives prescribing is post-approval evidence. Where is it strongest and where is it thin?