On average, the 80 mg/day dose did not provide additional benefit compared to the 40 mg/day dose.SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: confidence interval, unadjusted for multiple comparisons. Worked well. AdultsThe recommended starting dose of Latuda is 40 mg once daily. Some people may have a particularly high risk of having suicidal thoughts or actions.How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:Before taking Latuda, tell your healthcare provider about all of your medical conditions, including if you:Tell your healthcare provider about all the medicines you takeStroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death.Neuroleptic malignant syndrome (NMS) a serious condition that can lead to death.Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with Latuda:increased fat levels (cholesterol and triglycerides) in your blood.Increased prolactin levels in your blood (hyperprolactinemia).Decreased blood pressure (orthostatic hypotension).Problems controlling your body temperature so that you feel too warm.Children 10 to 17 years of age with bipolar depression:General information about the safe and effective use of Latuda.PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 20 mg, 30 Tablet LabelPACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 40 mg, 30 Tablet LabelPACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 60 mg, 30 Tablet LabelPACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 80 mg, 30 Tablet LabelPACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 120 mg, 30 Tablet LabelWe comply with the HONcode standard for trustworthy health information - Patients with severe neutropenia (absolute neutrophil count < 1000/mmLatuda may cause orthostatic hypotension and syncope, perhaps due to its α1-adrenergic receptor antagonism. *Somnolence includes adverse event terms: hypersomnia, hypersomnolence, sedation, and somnolence**EPS includes adverse event terms: akathisia, cogwheel rigidity, dyskinesia, dystonia, hyperkinesia, joint stiffness, muscle rigidity, muscle spasms, musculoskeletal stiffness, oculogyric crisis, parkinsonism, tardive dyskinesia, and tremorIn the short-term, placebo-controlled schizophrenia studies, for Latuda-treated patients, the incidence of reported events related to extrapyramidal symptoms (EPS), excluding akathisia and restlessness, was 13.5% and 5.8% for placebo-treated patients. Long-standing hyperprolactinemia, when associated with hypogonadism, may lead to decreased bone density in both female and male patients Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin-dependent In short-term, placebo-controlled schizophrenia studies, the median change from baseline to endpoint in prolactin levels for Latuda-treated patients was +0.4 ng/mL and was -1.9 ng/mL in the placebo-treated patients. In the short-term, placebo-controlled study of adolescents, fasting serum glucose mean values were -1.3 mg/dL for placebo (n=95), +0.1 mg/dL for 40 mg/day (n=90), and +1.8 mg/dL for 80 mg/day (n=92).Data from the adult short-term, flexible-dose, placebo-controlled monotherapy bipolar depression study are presented in Patients were randomized to flexibly dosed Latuda 20 to 60 mg/day, Latuda 80 to 120 mg/day, or placeboIn the uncontrolled, open-label, longer-term bipolar depression study, patients who received Latuda as monotherapy in the short-term study and continued in the longer-term study, had a mean change in glucose of +1.2 mg/dL at week 24 (n=129).Data from the adult short-term, flexible-dosed, placebo-controlled adjunctive therapy bipolar depression studies are presented in Patients were randomized to flexibly dosed Latuda 20 to 120 mg/day or placebo as adjunctive therapy with lithium or valproate.In the uncontrolled, open-label, longer-term bipolar depression study, patients who received Latuda as adjunctive therapy with either lithium or valproate in the short-term study and continued in the longer-term study, had a mean change in glucose of +1.7 mg/dL at week 24 (n=88).In studies of pediatric patients 10 to 17 years and adults with bipolar depression, changes in fasting glucose were similar. Caution patients about operating hazardous machinery, including motor vehicles, until they are reasonably certain that therapy with Latuda does not affect them adversely.In clinical studies with Latuda, somnolence included: hypersomnia, hypersomnolence, sedation and somnolence.In short-term, placebo-controlled schizophrenia studies, somnolence was reported by 17.0% (256/1508) of patients treated with Latuda (15.5% Latuda 20 mg, 15.6% Latuda 40 mg, 15.2% Latuda 80 mg, 26.5% Latuda 120 mg and 8.3% Latuda 160 mg/day) compared to 7.1% (50/708) of placebo patients.In the short-term, placebo-controlled adolescent schizophrenia study, somnolence was reported by 14.5% (31/214) of patients treated with Latuda (15.5% Latuda 40 mg and 13.5% Latuda 80 mg,/day) compared to 7.1% (8/112) of placebo patients.In the adult short-term, flexible-dosed, placebo-controlled monotherapy bipolar depression study, somnolence was reported by 7.3% (12/164) and 13.8% (23/167) with Latuda 20 to 60 mg and 80 to 120 mg, respectively compared to 6.5% (11/168) of placebo patients.In the adult short-term, flexible-dosed, placebo-controlled adjunctive therapy bipolar depression studies, somnolence was reported by 11.4% (41/360) of patients treated with Latuda 20-120 mg compared to 5.1% (17/334) of placebo patients.In the 6-week, placebo-controlled bipolar depression study in pediatric patients 10 to 17 years, somnolence was reported by 11.4% (20/175) of patients treated with Latuda 20 to 80 mg/day compared to 5.8% (10/172) of placebo treated patients.Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents.