Medication approval journey
lurasidone (Latuda)
Approved for Schizophrenia in adults and adolescents; bipolar depression
page first published · last updated
Also answers to “the dinner date” — its codename in our videos and posts. The full codebook
How this page reads
The page as written, with the clinical terms
Plain language uses the same facts, the same numbers and the same caveats. It does not leave anything out. Quotes from the FDA label are never reworded in either setting.
Before you stop or change your lurasidone dose
Stopping abruptly can be dangerous — never do it without medical supervision
Do not stop an antipsychotic abruptly. Abrupt withdrawal can cause rebound or supersensitivity psychosis and withdrawal movement disorders, and relapse risk is highest with the fastest reductions. Any change should be a slow, prescriber-supervised taper.
what the lurasidone warnings mean
label facts below are read from the Latuda (lurasidone hydrochloride) FDA label on DailyMed, set id afad3051-9df2-4c54-9684-e8262a133af8, version 37, effective january 31, 2025, the version the dossier above cites. the section numbers in brackets are the label’s own. every source is linked at the end of this section. last checked 2026-10-06.
lurasidone was approved on october 28, 2010 for schizophrenia in adults, and later for schizophrenia in adolescents aged 13 to 17, for the depressive episodes of bipolar i disorder in adults and children aged 10 to 17, and as an add-on to lithium or valproate for bipolar depression in adults [label 1; approval]. it is not approved for mania [label 2.2]. the federal survey this site uses for a scale line does not report a usable count for lurasidone in any year from 2014 to 2024: fewer than 60 respondents reported it in each year to 2021, under ahrq’s reliability rule, and from 2022 ahrq masks the name in the public file, so this page gives no number of people taking it [meps]. it is not a controlled substance [label 9.1]. its label opens with the same two-part boxed warning as quetiapine, one on deaths among older people with dementia and one on suicidal thoughts in young people, and runs through sixteen numbered warnings. its distinguishing facts are smaller than a warning: it has to be taken with a meal of at least 350 calories or about half of it is not absorbed, its weight and blood-sugar numbers are among the lowest in the class, and its movement side effects, especially the restlessness called akathisia, are among the highest. this section says what each means in plain words, what the approval trials measured and for how long, which side effects the label counts and how often, and what independent research has found since, in both directions. every number is from the label or from a study linked at the end.
this is information to take to a prescriber. nothing here is a reason to start, stop or change a dose on your own; the questions at the end are questions, and the quetiapine explainer this page is often compared with is linked at the end rather than repeated [quetiapine-explainer; compare].
the boxed warning, part one: deaths among older people with dementia-related psychosis
the first part of the boxed warning says that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death, and that lurasidone is not approved for them [label, boxed warning and 5.1]. the number behind it is a pooled analysis of 17 placebo-controlled trials, mostly of atypical antipsychotics and mostly about 10 weeks long: the death rate was about 4.5% on drug against about 2.6% on placebo, 1.6 to 1.7 times higher. most of the deaths were cardiovascular, such as heart failure or sudden death, or infectious, such as pneumonia [label 5.1; fda-dementia].
it is a class warning written from trials of several antipsychotics; lurasidone was not on the market when those trials ran, and the label does not claim a lurasidone-specific number. a related warning notes that in trials of risperidone, aripiprazole and olanzapine in elderly people with dementia there were more strokes and transient ischaemic attacks, including fatal ones, than on placebo [label 5.3]. the geriatric section adds that the trials did not include enough people over 65 to say whether they respond differently, and that whether the dose should change with age alone is unknown [label 8.5].
the boxed warning, part two: suicidal thoughts and behaviors, by age
the second part is the antidepressant class warning, which lurasidone carries because it is approved for bipolar depression. it says antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents and young adults in short-term studies, and that everyone treated should be watched closely for worsening, especially in the first months and after a dose change [label, boxed warning and 5.2]. the label states the difference against placebo per 1,000 people treated: under 18, 14 additional people with suicidal thoughts or behaviors; 18 to 24, 5 additional; 25 to 64, 1 fewer; 65 and older, 6 fewer [label 5.2, table 2]. the pooled trials covered about 77,000 adults and more than 4,400 children on antidepressants generally, not lurasidone. no suicides occurred in the pediatric trials; the adult trials had too few to conclude anything about suicide itself [label 5.2].
so the warning has an age boundary that is printed in the label and rarely repeated: above age 24 the pooled trials did not show an increase, and above 65 the number runs the other way [label 5.2; age-ceiling]. the label says the risk beyond four months is unknown, and that prescribers should consider changing the regimen, including possibly stopping, in anyone whose depression is persistently worse or who develops suicidal thoughts [label 5.2]. that is an instruction to prescribers about watching, not an instruction to patients about stopping.
the food rule, and the drugs that change the dose
lurasidone should be taken with food of at least 350 calories. with food, the total amount absorbed roughly doubles and the peak level roughly triples, and every trial behind the approval gave it with food [label 2.3]. a dose taken on an empty stomach is therefore a smaller dose than the one that was tested. the label does not say what a 350-calorie meal is; a prescriber or pharmacist can.
the drug is cleared by the liver enzyme cyp3a4, and the label makes two groups of medicines contraindications rather than cautions. strong inhibitors (it names ketoconazole, clarithromycin, ritonavir, voriconazole and mibefradil) raise lurasidone levels and must not be taken with it; strong inducers (rifampin, st john’s wort, phenytoin, carbamazepine) lower them and must not be taken with it either [label 4; 7.1, table 34]. with a moderate inhibitor such as diltiazem, erythromycin, fluconazole or verapamil the label halves the dose, to a 20 mg start and an 80 mg ceiling; with a moderate inducer taken for a week or more it says the dose may need to go up [label 2.6]. grapefruit and grapefruit juice should be avoided, because they disable the same enzyme in the gut wall [label 2.6]; a review of grapefruit interactions lists lurasidone among the affected drugs and notes the effect lasts about a day after the fruit [grapefruit]. lithium and valproate do not change the dose [label 7.2]. the dose is also capped at 80 mg in moderate or severe kidney impairment and at 80 or 40 mg in moderate or severe liver impairment [label 2.4, 2.5].
the metabolic warning, with the label’s tables
warning 5.6 is the class warning that atypical antipsychotics cause hyperglycemia and diabetes, undesirable lipid changes and weight gain, that each drug has its own profile, and that fasting glucose should be tested at the start and periodically in anyone with diabetes risk factors, with regular weight monitoring [label 5.6]. lurasidone’s own tables are unusual in the class for how small the numbers are. they stop at 6 weeks for the controlled data; the open-label extensions run to a year.
- weight, adults with schizophrenia [5.6, table 9]: mean change +0.43 kg on lurasidone against -0.02 kg on placebo over 6 weeks; 4.8% gained 7% or more of body weight against 3.3%. in the same trials the active comparators gained more: +4.15 kg on olanzapine and +2.09 kg on quetiapine extended-release [5.6; 14.1]. in the open-label extensions, mean weight was 0.69 kg below baseline at 24 weeks and 0.73 kg below at 52 weeks.
- weight, bipolar depression [5.6, tables 11 to 13]: +0.29 kg against -0.04 kg as monotherapy (2.4% against 0.7% gaining 7% or more); +0.11 kg against +0.16 kg as an add-on to lithium or valproate (3.1% against 0.3%); in children aged 10 to 17, +0.7 kg against +0.5 kg (4.0% against 5.3%).
- weight, children and adolescents over two years [5.6; 8.4]: in the open-label study that followed the three pediatric trials, 378 of 701 stayed on lurasidone for 104 weeks and gained a mean 5.85 kg. adjusted for normal growth, the change in weight z-score was -0.06 standard deviations and in body-mass index -0.13, which the label calls minimal deviation from the normal curve. mean height gain was 4.94 cm, a z-score change of +0.05.
- blood sugar, adults with schizophrenia [5.6, table 3]: mean fasting glucose change ranged from -0.6 to +2.6 mg/dl across doses against -0.0 on placebo. the share crossing 126 mg/dl was 8.3% on placebo and, by dose, 11.7% (20 mg), 12.7% (40 mg), 6.8% (80 mg), 10.0% (120 mg) and 5.6% (160 mg), with no dose pattern. at 52 weeks of open-label treatment, the mean change was +2.3 mg/dl.
- blood sugar, bipolar depression and children [5.6, tables 4 and 5; 8.4]: +1.8 mg/dl on the lower dose range and -0.8 on the higher against +1.8 on placebo as monotherapy; -0.9 against +1.2 as an add-on. in the 104-week pediatric study, 7% of children with a normal fasting glucose at the start had shifted to high at the end.
- lipids, adults with schizophrenia [5.6, table 6]: total cholesterol fell on every arm including placebo (-5.8 mg/dl on placebo; -3.8 to -12.3 on lurasidone), and so did triglycerides (-13.4 on placebo; -3.1 to -29.1 on lurasidone). the share crossing 240 mg/dl total cholesterol was 5.3% on placebo and 3.8% to 13.8% by dose, the high figure from the 58-person 20 mg arm.
- lipids, children over two years [5.6; 8.4]: in the 104-week open-label study, 12% of children with normal total cholesterol at the start shifted to high, 3% for ldl, 12% for triglycerides, and 27% shifted from normal to low hdl.
movement side effects and restlessness: where lurasidone’s numbers run high
what the metabolic tables give back, the movement tables take. in the 6-week adult schizophrenia trials, any extrapyramidal event was reported by 21% at 40 mg, 23% at 80 mg, 39% at 120 mg and 20% at 160 mg against 9% on placebo [label 6.1, table 24]. akathisia, an inner restlessness with an urge to move that people often find the hardest side effect to live with, was 13% overall against 3%, and 22% at 120 mg [label 6.1, tables 19 and 24]. parkinsonism (stiffness, slowness, tremor) was 9% to 17% against 5%, and dystonia (muscle spasms, often of the neck, jaw or eyes) 4% to 7% against under 1% [label 6.1, table 24]. in adult bipolar depression the pattern repeats at lower rates: any extrapyramidal event 12% on 20 to 60 mg and 20% on 80 to 120 mg against 5% as monotherapy, and 24% against 13% as an add-on [label 6.1, tables 26 and 27]. in adolescents with schizophrenia, 14% against 5% [label 6.1, table 25]; in children with bipolar depression, 6% against 5% [label 6.1, table 28].
tardive dyskinesia [5.5] is the separate, potentially irreversible movement disorder that can follow long antipsychotic treatment. the label says it is impossible to predict who will develop it, that whether antipsychotics differ in their potential to cause it is unknown, that the risk rises with duration and cumulative dose, and that chronic treatment should be reserved for chronic illness with no equally effective, less harmful alternative, at the smallest dose and shortest duration that works, with the need reassessed periodically [label 5.5]. a meta-analysis of 41 studies in 11,493 people put the prevalence at 20.7% on the newer antipsychotics as a class against 30.0% on the older ones, and 7.2% in people who had never taken an older drug; it did not report lurasidone separately [carbon-2017]. neuroleptic malignant syndrome [5.4], a rare and potentially fatal reaction with high fever, rigid muscles, confusion and unstable pulse or blood pressure, has been reported with lurasidone; the label says stop at once and treat in hospital.
the other warnings, in plain words
the warnings section runs from 5.1 to 5.16; the prolactin warning was revised in january 2025 [label, recent major changes]. beyond the boxed warnings, the metabolic one and the movement disorders:
- prolactin [5.7, revised january 2025]: lurasidone raises prolactin, which can suppress reproductive hormones and cause milk production, missed periods, breast enlargement in men and impotence, and over years lower bone density. in the adult schizophrenia trials the median change was +0.4 ng/ml against -1.9 on placebo, with a dose pattern: at 120 and 160 mg the median rise in women was 6.7 and 7.1 ng/ml [table 14]. a rise to five times the upper limit of normal occurred in 2.8% against 1.0%, and in 5.7% of women against 2.0% [5.7]. in the 104-week pediatric study, 2% had a markedly high level at some point; among boys there were no reports of gynecomastia or galactorrhea [5.7].
- low white cells [5.8]: leukopenia and neutropenia have been reported with antipsychotics, and fatal agranulocytosis with other drugs in the class. anyone with a low white count or a history of drug-induced neutropenia needs frequent blood counts in the first months.
- low blood pressure, fainting and falls [5.9, 5.10]: orthostatic hypotension was reported as an adverse event in 0.3% against 0.1%, and syncope in 0.1% against 0%; measured by vital signs it ran 0.8% to 2.1% by dose against 0.7%. the label asks for a fall-risk assessment in anyone whose other conditions or medicines add to drowsiness or unsteadiness.
- seizures [5.11]: 0.1% in both the lurasidone and placebo groups in the schizophrenia trials (2 of 1,508 against 1 of 708); none in the bipolar depression trials.
- drowsiness and impaired thinking [5.12]: somnolence in 17.0% against 7.1% in the adult schizophrenia trials, highest at 120 mg (26.5%) and lowest at 160 mg (8.3%); 7.3% to 13.8% against 6.5% in bipolar depression monotherapy; 11.4% against 5.1% as an add-on; 14.5% against 7.1% in adolescents; 11.4% against 5.8% in children with bipolar depression. the label says not to drive or operate machinery until the effect is known.
- mania [5.14]: fewer than 1% of people in both the lurasidone and placebo groups of the bipolar depression trials developed a manic or hypomanic episode.
- heat [5.13], swallowing [5.15], parkinson’s disease and lewy body dementia [5.16]: antipsychotics can impair the body’s cooling and have been linked to aspiration pneumonia; people with parkinson’s disease or dementia with lewy bodies are reported to be unusually sensitive to them, with confusion, falls and features resembling neuroleptic malignant syndrome.
- kidney blood tests [6.1, tables 29 to 33]: a shift in serum creatinine from normal to high occurred in 5% at 120 mg and 7% at 160 mg against 2% on placebo in adults with schizophrenia, in 7.2% against 2.9% in adolescents, and in 6.7% against 4.5% in children with bipolar depression. the label reports this as a laboratory finding and draws no conclusion from it.
- allergy [4; 6.2]: angioedema has been observed, and hypersensitivity reactions (hives, throat and tongue swelling, breathlessness, rash) and low sodium have been reported since marketing; because they are voluntary reports, no rate can be given.
- pregnancy [8.1]: babies exposed to any antipsychotic in the third trimester are at risk of movement and withdrawal symptoms after birth, from agitation and tremor to feeding and breathing problems; some recovered within hours or days, others needed prolonged hospital care. there are no studies of lurasidone in pregnant women, and the label says the available data cannot inform a risk of birth defects or miscarriage. a pregnancy registry exists.
what the approval trials measured, and for how long
schizophrenia in adults rests on five 6-week placebo-controlled trials of 145, 180, 473, 489 and 482 people, mean age 38. not every dose worked in every trial: in the 489-person trial only the 80 mg dose beat placebo, and 40 mg and 120 mg did not [label 14.1, table 35]. two trials carried an active comparator to show the trial could detect an effect, and in both the comparator scored higher than lurasidone on the primary scale: olanzapine 15 mg beat placebo by 12.6 points on the positive and negative syndrome scale where lurasidone 40 and 120 mg beat it by 9.7 and 7.5, and quetiapine extended-release 600 mg beat placebo by 17.5 points where lurasidone 80 and 160 mg beat it by 11.9 and 16.2 [label 14.1, table 35]. the label says these arms were "included for assay sensitivity", not to compare the drugs, and the trials were not designed to rank them. a 6-week trial in 326 adolescents found 40 and 80 mg both beat placebo by about 8 points, and that 80 mg gave no additional benefit over 40 [label 14.1, table 36].
bipolar depression rests on one 6-week monotherapy trial of 485 adults, in which both dose ranges beat placebo by 4.6 points on the montgomery-asberg scale and the higher range "did not provide additional efficacy"; one 6-week add-on trial of 340 adults, 3.6 points; and one 6-week trial of 343 children aged 10 to 17, 5.7 points on the children’s depression rating scale, with most children ending on 20 or 40 mg [label 14.2, tables 37 and 38]. a 6-week trial of 149 children with irritability associated with autism did not meet its primary endpoint, so there is no autism indication; vomiting ran 27% at 60 mg against 4% on placebo in that trial [label 8.4].
the arithmetic that matters: every controlled trial behind every indication was 6 weeks long. the label states it directly: "the effectiveness of latuda for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies", and the prescriber who continues it "should periodically re-evaluate the long-term usefulness of the drug for the individual patient" [label 2.3]. the safety database adds what the efficacy trials do not: 1,106 adults were followed for at least 24 weeks and 371 for at least 52 [label 6.1], and the longer-term weight, glucose, lipid and prolactin figures above come from those uncontrolled extensions.
side effects, with the label’s numbers
in the 6-week adult schizophrenia trials (1,508 on lurasidone against 708 on placebo), the reactions at 5% or more and at least twice placebo were somnolence, akathisia, extrapyramidal symptoms and nausea [label 6.1]. the table: somnolence 17% against 7%, extrapyramidal disorder 14% against 6%, akathisia 13% against 3%, nausea 10% against 5%, insomnia 10% against 8%, vomiting 8% against 6%, dyspepsia 6% against 5%, agitation 5% against 4%, anxiety 5% against 4%, dizziness 4% against 2%, back pain 3% against 2% [label 6.1, table 19]. dropouts for side effects were 9.5% against 9.3%, and no single reaction caused dropouts at twice the placebo rate [label 6.1].
in adult bipolar depression monotherapy (331 against 168): nausea 14% against 8%, somnolence 11% against 7%, akathisia 9% against 2%, extrapyramidal symptoms 7% against 2%, dry mouth 5% against 4%, anxiety 4% against 1% [label 6.1, table 20]; at the higher dose range nausea was 17% and somnolence 14%. as an add-on (360 against 334): nausea 14% against 10%, extrapyramidal symptoms 14% against 9%, somnolence 11% against 5%, akathisia 11% against 5%, restlessness 4% against under 1%, weight increased 3% against under 1% [label 6.1, table 21].
in adolescents with schizophrenia (214 against 112): somnolence 15% against 7%, nausea 14% against 3%, akathisia 9% against 2%, vomiting 8% against 2%, dizziness 5% against 1% [label 6.1, table 22]. in children with bipolar depression (175 against 172): nausea 16% against 6%, somnolence 11% against 6%, weight increased 7% against 2%, insomnia 5% against 2% [label 6.1, table 23]. one child in the two-year study, a 10-year-old boy, had a prolonged painful erection that led to stopping, an event not reported in adults [label 8.4]. in overdose, the only premarketing case was 560 mg, and the patient recovered without lasting harm [label 10.1].
what the research says, in both directions
in favour. in a network meta-analysis of 402 randomised trials covering 53,463 adults with schizophrenia, all 32 antipsychotics reduced symptoms more than placebo, and the drugs differed more in side effects than in effectiveness [huhn-2019]. on two of those side effects lurasidone sits at the favourable end: its qtc change against placebo, -2.21 milliseconds, was the smallest of the 32, and the abstract’s weight-gain range ran from -0.16 kg for ziprasidone to 3.21 kg for zotepine [huhn-2019, abstract]. a second network meta-analysis of 100 trials in 25,952 people ranked 18 antipsychotics on metabolic effects and named lurasidone, with aripiprazole, brexpiprazole, cariprazine and ziprasidone, as having the most benign profile; its glucose change against placebo, -0.29 mmol/l, was the lowest of the 18, where clozapine’s was +1.05 and olanzapine had the largest body-mass index and ldl rises [pillinger-2020; pillinger-2020, abstract]. that is the research behind the label’s small weight and glucose tables.
against, or smaller than it sounds. the same network meta-analysis found that efficacy differences between antipsychotics were "gradual rather than discrete" and that confidence in the evidence was "often low or very low" [huhn-2019, abstract]; lurasidone’s own approval trials include one in which two of three doses failed and two in which the comparator outscored it [label 14.1]. the metabolic advantage is bought with movement side effects: akathisia at 13% against 3% and any extrapyramidal event at 21% to 39% by dose are among the highest rates in this site’s explainers, where quetiapine’s fixed-dose schizophrenia trial showed none above placebo [label 6.1, table 24; quetiapine-explainer]. tardive dyskinesia remains at about one in five on the newer antipsychotics as a class [carbon-2017]. and every efficacy trial stopped at 6 weeks [label 2.3].
how long to stay on an antipsychotic, in both directions. none of this is lurasidone-specific; it is the class question the label’s 6-week trials cannot answer. a finnish register study of 8,719 people after a first schizophrenia admission found the lowest risk of rehospitalisation or death in those who stayed on an antipsychotic continuously, with the risk rising the longer treatment had lasted before it stopped, and death 174% to 214% higher among non-users and early stoppers; the people who stop are not a random sample [tiihonen-2018]. a dutch randomised trial of 128 people whose first episode had been in remission for six months found, seven years on, twice the recovery rate (40.4% against 17.6%) in those assigned to guided dose reduction rather than maintenance, with more early relapses along the way; it was small, open-label, and its authors asked for more studies before practice changes [wunderink-2013]. both belong in the conversation the label asks for when it says the need for continued treatment should be reassessed periodically [label 5.5].
questions to ask your prescriber about lurasidone
each one comes from a warning or a study above. they are questions, not instructions; the answers depend on a history nobody here has.
- the label says lurasidone must be taken with at least 350 calories or about half of it is not absorbed. what does that meal look like for me, and what happens on a day i skip it?
- my dose is above 80 mg. in the adult trials the 120 mg dose had akathisia at 22% and the highest somnolence, and in the bipolar depression trial the higher range gave no additional benefit. what is the higher dose for in my case?
- i feel restless and cannot sit still. the label counts akathisia at 13% against 3% on placebo. is that what this is, and what are the options?
- the label asks for fasting glucose and weight at the start and periodically, and reports prolactin rises mainly at 120 and 160 mg. when were mine last measured?
- i take an antifungal, an antibiotic such as clarithromycin or erythromycin, an hiv medicine, diltiazem or verapamil, carbamazepine, phenytoin, rifampin or st john’s wort, or i eat grapefruit. the label contraindicates some of these and halves the dose for others. is anything i take on that list?
- every controlled trial behind this drug was 6 weeks long, and the label asks for periodic re-evaluation of long-term usefulness. when is our next review, and what would tell us it is still working?
- if i am under 25 and taking this for bipolar depression, the boxed warning is about me. who is watching for worsening in the first months, and what exactly should they watch for?
- if i am over 65, or someone i care for has dementia: the boxed warning is about deaths in that group, and the label says there were too few older people in the trials to know whether the dose should differ. what is the plan for reviewing whether the drug is still needed?
questions people ask
- what does the latuda (lurasidone) black box warning mean?
- it has two parts, the same two as quetiapine. first, in 17 placebo-controlled trials of antipsychotics in elderly people with dementia-related psychosis, about 4.5% died over roughly ten weeks against about 2.6% on placebo, 1.6 to 1.7 times the rate, mostly from heart or infectious causes; lurasidone is not approved for that group. second, antidepressants increased suicidal thoughts and behavior in people under 25 in short-term trials (14 extra cases per 1,000 under 18, 5 extra at 18 to 24, 1 fewer at 25 to 64, 6 fewer at 65 and over), and lurasidone carries that warning because it is approved for bipolar depression. neither part is an instruction to stop; both describe who should be watched, and for what.
- why does latuda have to be taken with food?
- because the label says administration with at least 350 calories roughly doubles the amount absorbed and roughly triples the peak level, and every trial behind the approval gave it with food. taken on an empty stomach, the same tablet delivers a smaller dose than the one that was tested. the label does not define the meal beyond the calorie figure; a pharmacist can.
- does latuda cause weight gain?
- less than most antipsychotics, on the label’s own numbers. in the 6-week adult schizophrenia trials mean weight change was +0.43 kg against -0.02 kg on placebo, and 4.8% gained 7% or more of body weight against 3.3%; in the same trials olanzapine gained 4.15 kg and quetiapine extended-release 2.09 kg. in the open-label extensions, mean weight at one year was slightly below baseline. a network meta-analysis of 18 antipsychotics placed lurasidone among the five with the most benign metabolic profile. children in the two-year open-label study gained a mean 5.85 kg, which the label calls minimal deviation from normal growth once adjusted for age.
- what are the most common latuda side effects?
- in the adult schizophrenia trials: somnolence 17% vs 7% on placebo, extrapyramidal symptoms 14% vs 6%, akathisia (inner restlessness) 13% vs 3%, nausea 10% vs 5%. akathisia reached 22% at 120 mg. in bipolar depression: nausea 14% vs 8%, somnolence 11% vs 7%, akathisia 9% vs 2%. in children with bipolar depression: nausea 16% vs 6%, weight increase 7% vs 2%. movement side effects are where lurasidone’s numbers run higher than quetiapine’s; weight and blood sugar are where they run lower.
- latuda vs seroquel: what does the public record show?
- two drugs with the same two-part boxed warning and opposite side-effect profiles. the lurasidone label shows +0.43 kg of weight gain over 6 weeks and akathisia in 13% of people; the quetiapine label shows 23% of people gaining 7% or more of their weight in the same period and no movement side effects above placebo in its fixed-dose schizophrenia trial. in the one approval trial that included both, quetiapine extended-release 600 mg beat placebo by more points than lurasidone 80 or 160 mg, but the label says that arm was there to check the trial worked, not to compare the drugs. lurasidone must be taken with food; quetiapine is far more sedating (somnolence 57% in its bipolar depression trials against 11% for lurasidone). the quetiapine explainer and the side-by-side comparison page are linked in the sources. which fits a given person is a prescriber conversation.
- is latuda (lurasidone) a controlled substance or addictive?
- it is not a controlled substance. the label says lurasidone "has not been systematically studied in humans for its potential for abuse or physical dependence", that the trials showed no drug-seeking behaviour, and that this is not enough to predict misuse once marketed, so people with a history of drug misuse should be watched for tolerance, dose escalation and drug-seeking.
- how long do people take latuda for, and how long was it tested?
- every controlled trial behind every indication lasted 6 weeks, and the label states that effectiveness beyond 6 weeks "has not been established in controlled studies", asking prescribers who continue it to re-evaluate its usefulness periodically. the safety database followed 1,106 adults for at least 24 weeks and 371 for at least 52. how long to stay on an antipsychotic is a class question: a finnish register study found the lowest rehospitalisation and death rates in people who stayed on treatment, and a small dutch randomised trial found twice the recovery rate seven years after guided dose reduction in people already in remission. a plan for reducing or stopping belongs with a prescriber.
sources for this section
the library rows link to our one-page summary of each study, with the original paper, its funding and our evidence grade on that page.
- latuda (lurasidone hydrochloride) tablets prescribing information, fda label on dailymed (set id afad3051-9df2-4c54-9684-e8262a133af8, version 37, effective january 31, 2025; sumitomo pharma america): boxed warning; sections 1, 2.2 to 2.6, 4, 5.1 to 5.16 with tables 2 to 18, 6.1 tables 19 to 33, 6.2, 7.1 table 34, 7.2, 8.1, 8.4, 8.5, 9.1, 9.2, 10.1, 14.1 and 14.2 with tables 35 to 38, recent major changes
- drugs@fda, nda 200603 (latuda), approved october 28, 2010
- ahrq medical expenditure panel survey, prescribed medicines public-use files 2014 (hc-168a) to 2024 (hc-254a): lurasidone has no reportable year (fewer than 60 respondents in 2014 to 2021; name masked in the public file for 2022 to 2024); method on the usage section of this page
- the antipsychotic dementia-mortality warning as a library row: the 17-trial pooled analysis, the 2005 and 2008 fda actions, and the questions it raises (library row)
- the antidepressant suicidality warning’s age ceiling, from the labels themselves, as a library row (library row)
- huhn m, et al. comparative efficacy and tolerability of 32 oral antipsychotics for the acute treatment of adults with multi-episode schizophrenia: a systematic review and network meta-analysis. lancet 2019 (library row written up for aripiprazole; the lurasidone qtc figure and the quoted conclusions are from the abstract, pubmed 31303314) (library row)
- pillinger t, et al. comparative effects of 18 antipsychotics on metabolic function in patients with schizophrenia, predictors of metabolic dysregulation, and association with psychopathology: a systematic review and network meta-analysis. lancet psychiatry 2020 (library row written up for aripiprazole; the lurasidone glucose figure is from the abstract, pubmed 31860457; uk medical research council and wellcome trust funding) (library row)
- carbon m, hsieh ch, kane jm, correll cu. tardive dyskinesia prevalence in the period of second-generation antipsychotic use: a meta-analysis. journal of clinical psychiatry 2017 (library row)
- tiihonen j, tanskanen a, taipale h. 20-year nationwide follow-up study on discontinuation of antipsychotic treatment in first-episode schizophrenia. american journal of psychiatry 2018 (register study; the row records the selection caution) (library row)
- wunderink l, et al. recovery in remitted first-episode psychosis at 7 years of follow-up of an early dose reduction/discontinuation or maintenance treatment strategy. jama psychiatry 2013 (randomised, open-label, 128 people) (library row)
- bailey dg, dresser g, arnold jm. grapefruit-medication interactions: forbidden fruit or avoidable consequences? cmaj 2013 (narrative review; lurasidone is in its tables) (library row)
- what the quetiapine (seroquel) warnings mean, the companion explainer on this site, written from the quetiapine label the same way
- latuda vs seroquel: the public record side by side (usage, payers, label warnings, approval history), a separate page on this site
How long the lurasidone 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.
People often stay on these drugs for far longer than the trials ran. The trials behind the approval ran 6 weeks.
That does not mean longer use is unsafe. It does not mean the drug stops working either. It means longer use was never the thing that got tested.
If you have been on it a long time, that is a fair thing to ask your prescriber about.
Boxed warning: increased mortality in elderly patients with dementia
The strongest warning the FDA puts on a label, often called a black box warning. It is reproduced below word for word, not summarised.
This is the strongest warning the FDA can put on a drug label. Some people call it a black box warning. We copied it word for word. We did not shorten it and we did not soften it.
The lurasidone boxed warning covers increased mortality in elderly patients with dementia and suicidal thoughts and behaviors.
The warning below covers two things. The first is about older people. Older people who have dementia with psychosis are more likely to die if they take antipsychotic drugs. This drug is not approved for that. The second is about young people. In short studies, antidepressants raised the risk of suicidal thoughts and behavior. That was in children, teens, and young adults.
The FDA’s own words follow, copied exactly.
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LATUDA is not approved for the treatment of patients with dementia-related psychosis ( 5.1 ). Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients. Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.2 ). Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LATUDA is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )]. Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.2 )].
FDA label effective January 31, 2025 — read the full label on DailyMed
What lurasidone is FDA approved for, and the trials behind it
Approved for treatment of schizophrenia; the 2010 approval was followed later by the adolescent and bipolar-depression indications in 2010, under application NDA 200603. Source: FDA Drugs@FDA.
The label describes five short-term, 6-week, placebo-controlled studies in adults with schizophrenia (mean age 38.4, range 18-72), enrolling 145 to 489 patients each and testing fixed doses from 40 to 160 mg/day. Two of the studies added an active-control arm — olanzapine in one, quetiapine extended-release in the other — to assess assay sensitivity. Lurasidone was superior to placebo on symptom scales at 40, 80, 120, and 160 mg/day, though not every dose separated from placebo in every study.
The FDA approved lurasidone in 2010. The approved use was schizophrenia. Uses in teens and in bipolar depression came later. The file number is NDA 200603. The source is Drugs@FDA, the FDA's own database.
The label describes five short 6-week trials against a placebo. Everyone was an adult with schizophrenia. Their average age was 38.4, and they ranged from 18 to 72.
Each trial held 145 to 489 people. Set doses ran from 40 to 160 mg a day.
Two of the trials added an arm on another active drug. One used olanzapine and the other used slow-release quetiapine. That was to check the trial could tell drugs apart at all.
The drug beat the placebo on symptom scales at 40, 80, 120, and 160 mg a day. But not every dose beat the placebo in every trial.
- Trials
- 5 placebo-controlled studies
- Duration
- 6 weeks
- Participants
- 145 to 489 patients per study
- Compared against
- Placebo; olanzapine or quetiapine XR in two studies
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. An active-control arm (olanzapine or quetiapine extended-release) was included in two studies to assess assay sensitivity.
Verbatim from the lurasidone FDA label, Clinical Studies section, effective January 31, 2025 — read the full label on DailyMed.
Side effects of lurasidone in the approval trials
Incidence among 1,508 patients on lurasidone (20 to 160 mg/day) versus 708 on placebo in the adult short-term (up to 6 weeks) schizophrenia studies. The label cautions that adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Akathisia and extrapyramidal symptoms were dose-related.
Read the limits first. These numbers come from the short adult schizophrenia trials, which ran up to 6 weeks. 1,508 people took the drug at 20 to 160 mg a day. 708 took a placebo.
Two effects went up with the dose. Those were trouble sitting still (akathisia) and stiff or shaky muscle effects.
The label warns that you cannot line these rates up against another drug’s trials. It warns that real life may not match them either.
Extrapyramidal symptoms and akathisia on the lurasidone label
The lurasidone FDA label names extrapyramidal symptoms and akathisia in its Adverse Reactions section, in the list below.
- Somnolence (17% vs 7% on placebo)
- Extrapyramidal symptoms (14% vs 6%)
- Akathisia (13% vs 3%)
- Nausea (10% vs 5%)
- Insomnia (10% vs 8%)
- Vomiting (8% vs 6%)
- Dyspepsia (6% vs 5%)
- Agitation (5% vs 4%)
- Anxiety (5% vs 4%)
- Dizziness (4% vs 2%)
The most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) in patients treated with LATUDA were somnolence, akathisia, extrapyramidal symptoms, and nausea.
From the lurasidone FDA label, Adverse Reactions section, effective January 31, 2025 — DailyMed.
More from the lurasidone label: drug abuse and dependence
Not a controlled substance
Lurasidone is not a controlled substance under the Controlled Substances Act.
FDA label, Drug Abuse and Dependence section.
Abuse potential not systematically studied
Lurasidone has not been systematically studied in humans for its potential for abuse or physical dependence or its ability to induce tolerance. The label notes the clinical studies revealed no tendency for drug-seeking behavior, but calls those observations unsystematic, and advises evaluating patients for a history of drug abuse.
FDA label, Drug Abuse and Dependence section.
How many Americans take lurasidone
Survey-based federal estimates, published with a lag of about two years. They count prescriptions filled, not outcomes.
These are federal survey numbers. They come out about two years late. They count prescriptions filled. They do not tell you if the drug helped.
No year from 2014 to 2024 meets AHRQ’s reliability rule for this drug, so we print no count. Years not shown, under AHRQ’s reliability rule: 2014, 2015, 2016, 2017, 2018, 2019, 2020, 2021 (fewer than 60 survey respondents); 2022, 2023, 2024 (AHRQ masks the name in the public file).
Correction (29 September 2026). An earlier version of this section took its numbers from ClinCalc DrugStats, a third-party site that republishes this survey; we now compute them from AHRQ’s public-use files ourselves. It showed 385,353 people and 2,433,438 prescriptions for 2021. No year meets AHRQ’s reliability rule for this drug, so that count is removed. It said prescriptions were up 66% since 2014; too few years meet the rule to show a trend, so that line is removed.
Source: AHRQ Medical Expenditure Panel Survey (MEPS), Prescribed Medicines public-use files, 2014 (HC-168A) through 2024 (HC-254A), computed by veisund. People with at least one purchase where the Multum generic name (RXDRGNAM) equals the drug, weighted by the year’s person weight; purchases include refills. Standard errors by Taylor linearization on VARSTR/VARPSU. AHRQ’s reliability rule: a year is not shown when fewer than 60 survey respondents reported the drug or the relative standard error is over 50%. AHRQ cautions that its 2018 questionnaire redesign and the 2020–2022 pandemic years make year-to-year comparisons less certain.
What people report to the FDA about lurasidone
Read this before the numbers.
Anyone can file an adverse event report — patients, doctors, manufacturers — and nobody verifies that the drug caused what was reported. There is no denominator: tens of millions of prescriptions generate reports at an unknowable rate, and reporting rises with news coverage, not necessarily with harm. Counts below are report volumes, not rates, and cannot be compared between drugs. The FDA itself says not to use this data to make medical decisions — we show it because you deserve to see what is in the public record, with its limits stated plainly.
Read this before the numbers.
Anyone can send a report to the FDA. Patients can. Doctors can. Drug makers can. Nobody checks that the drug caused what the report describes.
There is also no bottom number. Tens of millions of prescriptions turn into reports at a rate nobody knows. Reports go up when a drug is in the news, and that is not the same as more harm.
So these are counts of reports. They are not rates. You cannot use them to compare one drug with another. The FDA itself says not to use this data to make medical choices.
We show it because it is on the public record, and you should get to see it with its limits named.
- 20,803
- reports mentioning lurasidone, all time
- 9,272
- filed as serious (a report-level flag covering every drug and outcome in the report)filed as serious. That flag covers the whole report, and one report can name more than one drug and more than one outcome.
Most-reported reactions
- Off label use2,078
- Drug ineffective1,864
- Anxiety1,236
- Feeling abnormal1,170
- Depression1,142
- Weight increased1,095
- Somnolence1,076
- Nausea1,051
- Insomnia1,014
- Suicidal ideation979
“Drug ineffective” ranking this high is worth noticing: a report of not being helped counts as an adverse event too, and people file them in large numbers.
It is worth noticing how high “drug ineffective” ranks. A report that the drug did not help counts as an adverse event too. People file a lot of them.
Source: FDA Adverse Event Reporting System (FAERS), via openFDA, openFDA dataset refreshed 2026-07-30 (the refresh date of the query endpoint, not the date reports run through).
Drug interactions listed on the lurasidone label
The FDA label’s interactions section, verbatim. A pharmacist checking your actual medication list beats any published list — including this one.
Below is the part of the FDA label that lists other drugs. It is copied word for word.
No list on the web can see what else you take. A pharmacist can. Ask one to check your full list.
Read the label’s interactions section
7 DRUG INTERACTIONS
7.1 Drugs Having Clinically Important Interactions with LATUDA Table 34: Clinically Important Drug Interactions with LATUDA Strong CYP3A4 Inhibitors Clinical Impact: Concomitant use of LATUDA with strong CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of LATUDA alone [see Clinical Pharmacology ( 12.3 )] . Intervention: LATUDA should not be used concomitantly with strong CYP3A4 inhibitors [see Contraindications ( 4 )] . Examples: Ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of LATUDA with moderate CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of LATUDA alone [see Clinical Pharmacology ( 12.3 )] . Intervention: LATUDA dose should be reduced to half of the original level when used concomitantly with moderate inhibitors of CYP3A4 [see Dosage and Administration ( 2.6 )] . Examples: Diltiazem, atazanavir, erythromycin, fluconazole, verapamil Strong CYP3A4 Inducers Clinical Impact: Concomitant use of LATUDA with strong CYP3A4 inducers decreased the exposure of lurasidone compared to the use of LATUDA alone [see Clinical Pharmacology ( 12.3 )] . Intervention: LATUDA should not be used concomitantly with strong CYP3A4 inducers [see Contraindications ( 4 )] . Examples: Rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine Moderate CYP3A4 Inducers Clinical Impact: Concomitant use of LATUDA with moderate CYP3A4 inducers decreased the exposure of lurasidone compared to the use of LATUDA alone [see Clinical Pharmacology ( 12.3 )] . Intervention: LATUDA dose should be increased when used concomitantly with moderate inducers of CYP3A4 [see Dosage and Administration ( 2.6 )] . Examples: Bosentan, efavirenz, etravirine, modafinil, nafcillin
7.2 Drugs Having No Clinically Important Interactions with LATUDA Based on pharmacokinetic studies, no dosage adjustment of LATUDA is required when administered concomitantly with lithium, valproate, or substrates of P-gp or CYP3A4 [see Clinical Pharmacology ( 12.3 )] .
FDA label for lurasidone, effective January 31, 2025 — DailyMed.
Label history: when this label changes, it is recorded in What changed.
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
- Read the under-65 group correctly before the numbers: 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. The beneficiary total sums brand-level rows, so treat it as an upper bound on distinct people. 124,110 beneficiaries filled 853,499 claims in 2024 — 38,814 aged 65 and over, and 85,296 under 65.
- 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)
- No figure. In AHRQ’s MEPS 2024 Prescribed Medicines file, AHRQ masks this drug in the 2024 public-use file (it withholds drug names it estimates fewer than about 400,000 people use), so no public all-payer count exists.
- 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.
Who has been paying for lurasidone, 2019–2024
Medicare Part D
Claims, all ages — the one payer with a public per-drug series.
856,074 → 853,499 claims
Medicare under 65
Beneficiaries, not ordinary working-age adults: Medicare before 65 means the disabled and dual-eligible population. A gap is a suppressed split, not zero.
92,789 → 85,296 beneficiaries
Medicaid
A floor each year — small-cell rows are suppressed federally and excluded from the sum.
1,069,475 → 1,109,001 prescriptions (floor)
Commercially insured adults
No public dataset publishes per-drug commercial claims for any year — the absence is the finding, and it is rendered, not interpolated. The population this library most wants to inform is the one with no public per-drug series, in any year — insurers and PBMs hold that data privately. What the federal surveys do measure — how many adults take these medications at all — is on the adult-usage page.
Sources: Medicare Part D Prescribers by Geography and Drug (data.cms.gov, national rows, per data year); Medicaid State Drug Utilization Data (data.medicaid.gov, national rows). Claims, fills and beneficiaries are different units — compare each series only with itself.
The lurasidone approval, step by step
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.
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
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.
Step 4
What independent research has found since
What has been learned by people who were not selling it?
Grapefruit interacts with more than 85 drugs, including buspirone, quetiapine, lurasidone, ziprasidone and pimozide
3 years after approval
The one interaction in this wave that comes from the breakfast table.
Significant findings
Bailey, Dresser and Arnold (CMAJ, 2013) reviewed the grapefruit literature. "Currently, more than 85 drugs ... are known or predicted to interact with grapefruit," and between 2008 and 2012 the number with the potential for serious adverse effects rose "from 17 to 43."
The mechanism is furanocoumarins in the fruit causing "irreversible inactivation" of the enzyme CYP3A4 in the small intestine, so that drugs normally broken down there reach the blood in larger amounts. Because the enzyme is destroyed rather than blocked, the effect outlasts the fruit: a dose taken within 4 hours of grapefruit shows the maximal interaction, at 10 hours the effect is "50% of the maximum," at 24 hours "25% of the maximum." "One whole grapefruit or 200 mL of grapefruit juice is sufficient" to produce a clinically relevant effect.
On who is affected: "Older people appear to be an especially vulnerable population for grapefruit-drug interactions," with pronounced effects in patients over 70.
The psychiatric and neurological drugs in the review's tables include buspirone, quetiapine, lurasidone, ziprasidone, pimozide, dextromethorphan, oral ketamine, oxycodone, oral fentanyl and triazolam.
Worth asking
Most of the drugs on the list are raised, not lowered, which for an antipsychotic means more sedation and, for pimozide and ziprasidone, more QT prolongation. The pharmacist's answer to "can I drink grapefruit juice" depends entirely on which drugs you take, and the review's 24-hour figure means "not at the same time as the pill" is not the same as "not at all." Seville oranges, used in marmalade, contain the same compounds.
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?
Deciding about lurasidone?
- Side-effect rates from lurasidone's own label — drug vs placebo, with every caveat the label attaches
- How long every medication's approval trials ran — lurasidone beside every other drug in the library, from the same FDA record
- 12 questions to ask before starting a psychiatric medication — each with the study behind it
- Already on it? The 10-question annual review — including the honest case for staying
- How long every drug here was tested before approval — one chart, all medications
Open lurasidone (Latuda) in veisund
The app has the full approval journey, the resources behind it, and people working through the same questions.
