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Lurasidone
Indications
Lurasidone is a second-generation (atypical) antipsychotic drug with a distinct receptor-binding profile that differentiates it from other drugs in this class.
FDA-Approved Indications
Lurasidone was initially approved by the US Food and Drug Administration (FDA) for the treatment of schizophrenia in adults. In 2009, the manufacturer initiated the lurasidone bipolar program (PREVAIL) to support approval for the treatment of bipolar disorder (type I). The program aimed to evaluate the safety and efficacy of lurasidone in this population. Based on the study results, lurasidone received FDA approval in June 2013 for the treatment of bipolar I disorder, both as monotherapy and as an adjunct to lithium or valproate. This approval was significant, as lurasidone was the first drug approved for both indications.
In March 2018, the FDA expanded the usage to include pediatric patients (aged 10-17) to treat major depressive episodes associated with bipolar I disorder.[1][2][3][4]
In January 2017, lurasidone received FDA approval for the treatment of schizophrenia in adolescents.[5][6]
Off-Label Uses
Lurasidone is sometimes used off-label to treat irritability associated with autism spectrum disorder.[7][8] This drug may also be used for the treatment of depression associated with bipolar disorder (type II) and mixed depressive episodes.[9][10]
The International Society for Bipolar Disorder and the Canadian Network for Mood and Anxiety guidelines indicate that no drugs currently meet the criteria for first-line treatment of Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5) manic or depressive episodes with mixed features. Lurasidone and cariprazine are recommended as second-line options.[11]
Mechanism of Action
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Mechanism of Action
Lurasidone belongs to the benzisothiazole class of antipsychotics. Although the mechanism of action of lurasidone is not fully understood, it is believed to affect both dopamine and serotonin receptors.[12] Lurasidone acts as a full antagonist at dopamine D2 and serotonin 5-HT2A and 5-HT7 receptors [13][14] and as a partial agonist at the serotonin 5-HT1A receptor. Compared with other atypical antipsychotics, lurasidone has the highest binding affinity for the 5-HT7 receptor.[15]
Blockade of D2 and 5-HT2A receptors confers the atypical antipsychotic properties of lurasidone. In addition, antagonism at the 5-HT7 receptor and partial agonism at the 5-HT1A receptor contribute to the antidepressant properties of lurasidone.
Lurasidone has low affinity for muscarinic M1, histamine H1, and alpha-1 and alpha-2A adrenergic receptors. This limited activity minimizes the risk of orthostatic hypotension, sedation, weight gain, and cognitive blunting, which are commonly associated with other antipsychotic agents.[14][16]
Pharmacokinetics
Absorption: Lurasidone is well absorbed after oral administration, with peak serum concentrations occurring approximately 1 to 3 hours after dosing. Steady-state concentrations are typically achieved within approximately 7 days. Food significantly increases the absorption of lurasidone. Because the drug is poorly soluble in water after oral ingestion, it should be administered with a meal containing at least 350 calories, regardless of its fat content, thereby increasing its bioavailability from 9% to 19%.[17]
Distribution: Lurasidone has a high apparent volume of distribution, approximately 6173 liters. Lurasidone has high plasma protein binding (~99%), primarily to albumin and alpha-1 acid glycoprotein.[18][19]
Metabolism: Lurasidone is primarily metabolized by cytochrome P450 3A4 (CYP3A4) enzyme into 2 active metabolites.[20] As lurasidone is not a substrate of CYP1A2, smoking is unlikely to affect its pharmacokinetics.
Excretion: Lurasidone is predominantly excreted in the feces (~80%) and, to a lesser extent, in the urine (~9%). The mean elimination half-life of lurasidone is approximately 18 hours.
Administration
Available Dosage Forms and Strengths
Lurasidone is supplied as oral tablet formulations. Lurasidone is available as immediate-release tablets in 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg strengths.
Adult Dosage
Lurasidone should be administered with a meal of at least 350 calories, regardless of fat content, to enhance its bioavailability.[17][21]
The recommended starting dosage of lurasidone for the treatment of schizophrenia in adults and adolescents is 40 mg once daily. The maximum dosage is 160 mg once daily in adults and 80 mg once daily in adolescents. Dosage should be individualized based on clinical response and tolerability.[22]
For bipolar depression, the recommended starting dosage in adults and pediatric patients is 20 mg once daily, with a maximum recommended dosage of 120 mg once daily in adults and 80 mg once daily in pediatric patients.
Specific Patient Populations
Hepatic impairment: Dosage adjustment is recommended for patients with moderate hepatic impairment (Child-Pugh score 7-9). The suggested starting dosage is 20 mg per day. In moderate hepatic impairment, the lurasidone dosage should not exceed 80 mg per day. In severe hepatic impairment (Child-Pugh score 10-15), the maximum recommended dosage should not exceed 40 mg per day.
Renal impairment: Dosage adjustment of lurasidone is advised in patients with moderate renal impairment (creatinine clearance 30 to <50 mL/min) and severe renal impairment (creatinine clearance <30 mL/min). The suggested initial dosage in moderate-to-severe renal impairment is 20 mg per day, with the maximum dosage not exceeding 80 mg per day.[23]
Pregnancy considerations: According to the 2024 guidelines from the Canadian Network for Mood and Anxiety Treatments (CANMAT), quetiapine and lamotrigine are recommended as first-line treatments for acute bipolar I depression during pregnancy. Lithium, which is considered a first-line agent outside the perinatal period, is classified as second-line in pregnancy because of safety and tolerability concerns. Emerging data on lurasidone suggest a favorable safety profile with no increased risk of adverse outcomes, but more clinical data are needed.[24] The Pregnancy Exposure Registry (1-866-961-2388) tracks pregnancy outcomes in women exposed to lurasidone during pregnancy (National Pregnancy Registry for Psychiatric Medications).[25]
Neonates exposed to antipsychotic medications during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms after delivery. There are currently no adequate studies on the use of lurasidone in pregnant women, and available data are insufficient to determine drug-related risks of congenital disabilities or miscarriage. Animal reproduction studies showed no teratogenic effects during organogenesis at doses approximately 1.5- and 6-fold the maximum recommended human dose. Extrapyramidal and withdrawal symptoms have been reported in neonates exposed to antipsychotics during the third trimester and may occasionally require hospitalization. Affected infants should be closely monitored, and symptoms should be managed appropriately.
Decisions regarding the continuation of antipsychotic therapy during pregnancy require a nuanced, individualized assessment of risks and benefits. Potential risks to fetal development must be weighed against the consequences of medication discontinuation, including relapse of severe mental illness, which can pose significant health risks to both the mother and infant.[25] A case report suggests that declining lurasidone levels during pregnancy may increase the risk of worsening bipolar disorder symptoms, highlighting the potential role of therapeutic monitoring and dose adjustment to reduce the risk of symptom exacerbation.[26]
Breastfeeding considerations: Lurasidone is over 99% bound to plasma proteins, making it unlikely to be excreted into breast milk in amounts that could affect a nursing infant. The relative infant dose is 1.16%, which is below the typical 10% threshold for infant safety.[27] Until more data are available, consideration of alternative medications may be prudent, especially when nursing a newborn or preterm infant.[28]
Pediatric patients: For schizophrenia, the safety and efficacy of lurasidone at 40 and 80 mg per day have been established in adolescents aged 13 to 17, and these dosages are approved by the FDA. Lurasidone is not FDA-approved for the treatment of schizophrenia in pediatric patients aged 13 or younger.
For bipolar I depression, the safety and effectiveness of lurasidone 20 to 80 mg per day have been established and are FDA-approved for pediatric patients aged 10 to 17.[29] However, the safety and efficacy of lurasidone for bipolar I depression have not been established in pediatric patients aged 10 or younger. Additionally, the safety and efficacy of lurasidone for the treatment of irritability associated with autistic disorder have not been established.
According to the Key Potentially Inappropriate Drugs in Pediatrics List, second-generation antipsychotics are associated with withdrawal-emergent dystonia or dyskinesia; therefore, rapid discontinuation should be avoided in patients aged 18 or younger. When considering metabolic risks, clozapine has the highest risk of causing metabolic syndrome, type 2 diabetes, and dyslipidemia, whereas aripiprazole and brexpiprazole have the lowest risk. Lurasidone is associated with a relatively lower metabolic risk compared with many other second-generation antipsychotics.[30]
Older patients: According to the 2023 American Geriatrics Society Beers criteria, the use of antipsychotic drugs in patients with dementia is associated with an increased risk of stroke, cognitive decline, and mortality. Use of antipsychotics, including lurasidone, should be limited to FDA-approved indications for schizophrenia and bipolar disorder.[31] Additionally, as discussed in the pharmacokinetics section, lurasidone is predominantly bound to plasma proteins, primarily albumin and alpha-1 acid glycoprotein.[19] As levels of these proteins may be altered in older adults, caution is advised when prescribing lurasidone in this population.
Adverse Effects
Lurasidone offers a safety advantage compared with some other atypical antipsychotic agents. Treatment with lurasidone is associated with a lower risk of metabolic adverse effects, including hypercholesterolemia, hyperlipidemia, hyperglycemia, and weight gain, compared with risperidone, quetiapine, and olanzapine.[32]
In patients with schizophrenia, the most commonly reported adverse effects include nausea, akathisia, somnolence, sedation, and parkinsonism. Long-term use of lurasidone is associated with modest weight gain compared with other atypical antipsychotics, such as quetiapine and risperidone. Clinical trials and meta-analyses have reported significant, dose-dependent increases in prolactin levels with lurasidone.[17][33]
Lurasidone offers a similar adverse effects profile in patients with bipolar depression. The most commonly reported adverse effects include nausea, akathisia, headache, extrapyramidal symptoms, and sedation. There have been reports that lurasidone is associated with a 7% increase in baseline body weight. More clinical trials need to be conducted to establish the safety and tolerability of long-term use of lurasidone in patients with bipolar depression.[3]
Drug-Drug Interactions
Lurasidone is primarily metabolized by CYP3A4; therefore, caution is necessary when coadministered with strong CYP3A4 inducers or inhibitors.[16][34] Relevant drug-drug Interactions have been addressed in the Contraindications section below.
Contraindications
Lurasidone is contraindicated in patients with a known history of hypersensitivity reactions.[18] Angioedema has been reported as per the product labeling.
As lurasidone is primarily metabolized by CYP3A4, dosage adjustment is required when used concomitantly with moderate CYP3A4 inhibitors. In such cases, it is recommended that the lurasidone dose be reduced to half the original level, with a starting dose of 20 mg and a maximum of 80 mg per day. Similarly, when lurasidone is administered with moderate CYP3A4 inducers, the dose may be increased as needed based on clinical response.
- Examples of potent CYP3A4 inhibitors include clarithromycin, ritonavir, indinavir, ketoconazole, itraconazole, and grapefruit juice.
- Examples of moderate CYP3A4 inhibitors include verapamil, diltiazem, erythromycin, fluconazole, fluvoxamine, and tofisopam.
- Examples of strong CYP3A4 inducers include rifampin, phenytoin, carbamazepine, and St. John's wort.
- Examples of moderate CYP3A4 inducers include modafinil and armodafinil.
Box Warnings
According to the warnings issued by the FDA, lurasidone increases the risk of suicidal ideation in young adults and pediatric patients in short-term studies. However, available data on lurasidone are insufficient, and large randomized controlled trials and continuous post-marketing pharmacovigilance are needed to provide clear insights.[35][36] The FDA recommends close monitoring of patients for the emergence of suicidal thoughts and behaviors.
The FDA has also issued a boxed warning regarding an increased risk of mortality in older patients with dementia-related psychosis; further studies are required to clarify this risk.[37][38]
Monitoring
Therapeutic drug monitoring is necessary for patients with renal and hepatic impairments. Dosage adjustment is not recommended in cases of mild impairment; it is recommended only for moderate-to-severe impairment.
The FDA has warned against using lurasidone with strong CYP3A4 inducers or inhibitors. Close monitoring is necessary when lurasidone is used with mild inducers or inhibitors. As CYP1A2 does not metabolize lurasidone, smoking does not affect lurasidone’s pharmacokinetics.[39]
Furthermore, data on the incidence of serious adverse effects such as neuroleptic malignant syndrome, agranulocytosis, diabetic ketoacidosis, cancer, and osteoporosis remain undetermined. Some evidence suggests that high doses of lurasidone may cause small increases in thyroid-stimulating hormone (TSH) levels, although the clinical significance of this finding is uncertain.[40]
Vital signs, including orthostatic hypotension and fall risk, should be assessed regularly. Baseline and periodic monitoring of complete blood count, electrocardiogram (QTc interval), renal function, hemoglobin A1c, and liver function tests is recommended, especially in patients with preexisting comorbidities.[41][42][43]
Toxicity
Signs and Symptoms of Overdose
Data on lurasidone overdose are limited. A literature search revealed only one case report of acute lurasidone overdose. This case report describes an adult man aged 31 who overdosed on large amounts of lurasidone in an attempt to commit suicide. The quantity of lurasidone ingested was 8.5 times the upper maximum limit. The overdose occurred shortly after lunch, which increased the absorption of lurasidone. The patient presented with mild hypertension and slightly elevated TSH levels. The patient only required IV fluids and recovered without sequelae. TSH levels normalized within 3 weeks after the overdose.[40]
In the FDA-approved product labeling for lurasidone, there is a documented case report of an overdose. A patient ingested 560 mg of lurasidone and subsequently recovered without any negative sequelae. Clinicians involved in the case noted that there were no long-term adverse effects from the lurasidone overdose.
Management of Overdose
Currently, specific antidotes for lurasidone are not available. In cases of overdose, close monitoring is recommended for the prolongation of the QT interval, orthostatic hypotension, central nervous system depression, and tachycardia.[44] Hypotension and circulatory collapse should be managed with appropriate supportive measures. Epinephrine, dopamine, or other beta-agonist sympathomimetics should be avoided, as beta stimulation may worsen hypotension in the setting of lurasidone-induced alpha blockade.
In case of severe extrapyramidal symptoms, anticholinergic medication such as benzhexol (trihexyphenidyl) should be administered. Tardive dyskinesia can be treated with a VMAT2 inhibitor such as valbenazine. For seizures, benzodiazepines may be administered. For neuroleptic malignant syndrome, aggressive intravenous hydration, benzodiazepines, dantrolene, and bromocriptine are recommended.[45]
Enhancing Healthcare Team Outcomes
Lurasidone is clinically beneficial in treating patients with schizophrenia and bipolar depression.[46] Approximately 80% of patients with schizophrenia achieve an optimal response at doses of 40 to 80 mg of lurasidone per day. Lurasidone has also been shown to improve depressive symptoms in patients with schizophrenia, which is particularly important given the association between depression and suicide risk in this population.[47] Additional clinical trials are necessary to confirm any potential antisuicidal effects of lurasidone.
Patients with bipolar depression typically achieve an optimal clinical response with lurasidone at 20 to 60 mg per day. Although lurasidone has minimal metabolic adverse effects, it can cause akathisia, somnolence, sedation, and extrapyramidal adverse effects. These effects can be minimized by using an appropriate dose and administering the medication in the evening.
Although lurasidone does not significantly prolong the QTc interval, most sudden cardiac deaths in patients receiving atypical antipsychotics are dose-dependent. Therefore, careful monitoring is required when prescribing higher doses of lurasidone. Lurasidone offers the convenience of once-daily dosing, which is especially important for patients suffering from complex mental illnesses. Healthcare providers, including pharmacists, play a critical role in counseling patients to take the medication with a meal of at least 350 calories to enhance absorption. For patients who find these dietary requirements challenging, developing a water-soluble formulation of lurasidone could help improve absorption.[48]
In acute schizophrenia, lurasidone demonstrated efficacy comparable to quetiapine but was not superior to risperidone in 12-month studies. Data on its effectiveness in bipolar depression are more limited. In 2014, 2 randomized, double-blind clinical trials (PREVAIL) showed that lurasidone, both as monotherapy and as an adjunct to lithium or valproate, significantly reduced scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Clinical Global Impression for use in bipolar illness (CGI-BP).[3][49] More recently, in 2017, a randomized, placebo-controlled trial of lurasidone monotherapy in children and adolescents demonstrated a significant decrease in depressive and anxiety symptoms, along with improvements in overall quality of life.[50]
Data on the safety and efficacy of lurasidone use in older and pregnant or postpartum women are limited. Clinical studies in patients with schizophrenia indicate that lurasidone is generally well tolerated, with minimal adverse effects. However, additional high-quality, long-term randomized controlled trials are needed to establish its safety and efficacy in the treatment of bipolar depression.
Lurasidone therapy is most effective when managed by a coordinated healthcare team. The prescribing clinician initiates treatment based on clinical judgment, while nursing staff play a key role in counseling patients on dosing and administration, monitoring treatment progress during follow-up visits, and communicating any concerns to the prescriber. Pharmacists contribute by checking for potential drug–drug interactions, particularly given lurasidone’s CYP450 metabolism, verifying proper dosing, and providing additional patient counseling at the time of medication dispensing. In cases of overdose, emergency medicine and critical care teams stabilize the patient promptly, with toxicology consultation for complex situations.
Ongoing patient monitoring and support are essential components of therapy. Nurses ensure consistent follow-up, address patient questions, and report observations to the managing clinician. Optimal therapeutic outcomes are achieved through collaboration among an interprofessional healthcare team, including physicians, advanced practice providers, psychiatrists, clinical psychologists, specialty-trained nurses, and pharmacists, all communicating effectively to tailor treatment and ensure patient safety.
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