Atypical (Second-generation) Antipsychotic Pregnancy: SPC §4.6: no or limited data (<300 pregnancy outcomes) in pregnant women; animal studies insufficient; potential human risk unknown — lurasidone should not be used during pregnancy unless clearly necessary. Neonates exposed during the third trimester are at risk of extrapyramidal and/or withdrawal symptoms — monitor newborns carefully. Breast-feeding: excretion in human milk unknown; breast-feeding should be considered only if the potential benefit justifies the potential risk to the child.

Lurasidone

Brand names: Latuda

Lurasidone is an atypical (second-generation) antipsychotic used in the treatment of schizophrenia.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 37 mg once daily starting dose; effective dose range 37–148 mg once daily

Route: Oral (film-coated tablets, swallowed whole, taken with a meal)

Frequency: Once daily, at the same time every day

Max: 148 mg per day

SPC §4.2 (Latuda): 'The recommended starting dose is 37 mg of lurasidone once daily. No initial dose titration is required. It is effective in a dose range of 37 to 148 mg once daily... The maximum daily dose should not exceed 148 mg.' Dose increase based on physician judgement and observed clinical response. Patients on doses higher than 111 mg once daily who discontinue treatment for longer than 3 days should be restarted on 111 mg once daily and up-titrated to their optimal dose; for all other doses patients can be restarted on their previous dose. Interaction adjustment: with moderate CYP3A4 inhibitors, starting dose 18.5 mg and maximum 74 mg once daily; dose adjustment may be needed with mild/moderate CYP3A4 inducers (strong CYP3A4 inhibitors and inducers are contraindicated). Elderly: same as adults if normal renal function (CrCl ≥ 80 ml/min); caution with higher doses in patients ≥65 years, no data at 148 mg. Hepatic impairment: no adjustment in mild; in moderate (Child-Pugh B) and severe (Child-Pugh C) starting dose 18.5 mg, max 74 mg (moderate) and 37 mg (severe) once daily. Must be taken with food — exposure is significantly lower if taken without food. Paediatric (SPC §4.2): starting dose 37 mg once daily, effective range 37–74 mg once daily, maximum 74 mg daily; in children lurasidone should be prescribed by an expert in paediatric psychiatry (no per-kg dose stated, so paedDose is null).

Dose adjustments

Renal

SPC §4.2: no adjustment in mild renal impairment. In moderate (CrCl ≥30 and <50 ml/min), severe (CrCl >15 and <30 ml/min) and End Stage Renal Disease (CrCl <15 ml/min), recommended starting dose 18.5 mg with a maximum of 74 mg once daily. Should not be used in ESRD unless potential benefits outweigh potential risks; if used, clinical monitoring is advised.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients
Concomitant administration of strong CYP3A4 inhibitors (e.g. boceprevir, clarithromycin, cobicistat, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole)
Concomitant administration of strong CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, St John's wort)

Side effects

Very common: akathisia, somnolence, parkinsonism, nausea, insomnia
Common: dizziness, dystonia, dyskinesia, agitation, anxiety, restlessness, vomiting, dyspepsia, salivary hypersecretion, dry mouth
Common: weight increased, decreased appetite, blood glucose increased, blood prolactin increased, tachycardia, hypertension, back pain, musculoskeletal stiffness, fatigue, blood creatinine phosphokinase increased
Uncommon: nightmare, catatonia, lethargy, dysarthria, blurred vision, vertigo, orthostatic hypotension, hot flush, rash, pruritus, hyperhidrosis, serum creatinine increased, amenorrhoea, erectile dysfunction
Rare/not known: neuroleptic malignant syndrome, tardive dyskinesia, syncope, convulsion, cerebrovascular accident, angioedema, Stevens-Johnson syndrome, rhabdomyolysis, suicidal behaviour, sudden death, neonatal drug withdrawal syndrome

Interactions

Strong CYP3A4 inhibitors (ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil) — contraindicated; markedly increase lurasidone exposure
Strong CYP3A4 inducers (rifampicin/rifampin, carbamazepine, phenytoin, phenobarbital, St John's wort) — contraindicated; decrease lurasidone exposure
Moderate CYP3A4 inhibitors (diltiazem, atazanavir, erythromycin, fluconazole, verapamil) — reduce lurasidone dose to half the original level; UK SPC: start 18.5 mg, max 74 mg once daily
Moderate CYP3A4 inducers — dose increase of lurasidone may be necessary
Other medicinal products thought to prolong the QT interval — caution (SPC §4.4)

Clinical monograph

How it works

It is an antagonist at dopamine D2 and serotonin 5-HT2A receptors, with additional activity at 5-HT7, 5-HT1A and noradrenergic alpha-2 receptors.

Prescribing in practice

Lurasidone should be taken with food to ensure adequate and reliable absorption, as bioavailability is substantially reduced when taken without food.
It is metabolised by CYP3A4, so co-administration with strong CYP3A4 inhibitors or inducers is contraindicated or requires dose adjustment per the SPC.
There is an increased risk of stroke and death in elderly patients with dementia-related psychosis, for which it is not indicated.

Monitoring

Monitor weight, blood glucose, lipids and for extrapyramidal symptoms or akathisia in keeping with standard antipsychotic monitoring.

Counselling the patient

Always take this medicine with food to make sure it is absorbed properly.
Avoid grapefruit and grapefruit juice while taking lurasidone.
Report restlessness, abnormal movements or muscle stiffness to your healthcare team.

Evidence & guidelines

Lurasidone is licensed for schizophrenia on the basis of randomised controlled trials and is recommended within NICE guidance on the treatment of psychosis and schizophrenia.

Reference: NICE TA810 (Lurasidone for Bipolar Depression); PREVAIL Trials; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways