Atypical antipsychotic Pregnancy: No or limited data (<300 pregnancy outcomes) in pregnant women; animal studies insufficient; potential risk for humans unknown. Lurasidone should not be used during pregnancy unless clearly necessary. Neonates exposed to antipsychotics during the third trimester are at risk of extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, feeding disorder) — newborns should be monitored carefully. Breast-feeding should be considered only if the potential benefit of treatment justifies the potential risk to the child.

Lurasidone hydrochloride

Brand names: Latuda

Lurasidone hydrochloride is a second-generation (atypical) antipsychotic used for schizophrenia and, in some settings, bipolar depression.

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 starting dose; effective dose range 37 mg to 148 mg

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

Frequency: Once daily, at the same time every day

Max: 148 mg daily

SPC §4.2 (Latuda 18.5mg film-coated tablets): '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.' Dose increase should be 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 without up-titration. DOSE ADJUSTMENT DUE TO INTERACTIONS: with moderate CYP3A4 inhibitors, starting dose 18.5 mg and maximum 74 mg once daily; dose adjustment may be necessary with mild and moderate CYP3A4 inducers; strong CYP3A4 inhibitors and inducers are contraindicated (§4.3). ELDERLY: dosing for elderly patients with normal renal function (CrCl ≥80 ml/min) is the same as for adults; dose adjustment may be required if renal function is diminished. Limited data in elderly on higher doses and NO data in elderly treated with 148 mg — caution when treating patients ≥65 years with higher doses. HEPATIC IMPAIRMENT: no adjustment in mild impairment; in moderate (Child-Pugh B) and severe (Child-Pugh C) the recommended starting dose is 18.5 mg, with maximum 74 mg daily in moderate and 37 mg once daily in severe. ADMINISTRATION: if taken without food, lurasidone exposure is anticipated to be significantly lower; swallow tablets whole to mask the bitter taste. PAEDIATRIC (§4.2, not a per-kg dose): '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 74 mg once daily... The maximum daily dose should not exceed 74 mg. In children, lurasidone should be prescribed by an expert in paediatric psychiatry.' No age range is specified in the fetched §4.2 text. Switching between antipsychotics requires supervision by a clinician.

Dose adjustments

Renal

No dose adjustment required 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 and maximum dose should not exceed 74 mg once daily. Lurasidone should not be used in patients with ESRD unless the potential benefits outweigh the potential risks; if used in ESRD, 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 (Hypericum perforatum))

Side effects

Akathisia (very common, ≥10%)
Nausea (very common, ≥10%)
Insomnia (very common, ≥10%)
Somnolence (including hypersomnia, hypersomnolence, sedation) and parkinsonism (common)
Weight increased; agitation, anxiety, restlessness; dizziness; blood prolactin increased (common)

Interactions

Strong CYP3A4 inhibitors — contraindicated (§4.3)
Strong CYP3A4 inducers — contraindicated (§4.3)
Moderate CYP3A4 inhibitors — starting dose 18.5 mg; maximum dose should not exceed 74 mg once daily (§4.2)
Mild and moderate CYP3A4 inducers — dose adjustment of lurasidone may be necessary (§4.2, see §4.5)
Other medicinal products thought to prolong the QT interval — caution; also in known cardiovascular disease, family history of QT prolongation and hypokalaemia (§4.4)

Clinical monograph

How it works

It is an antagonist at dopamine D2 and serotonin 5-HT2A receptors with additional 5-HT7 antagonism and 5-HT1A partial agonism, an action associated with antipsychotic effect and a relatively low metabolic burden.

Prescribing in practice

Lurasidone must be taken with food to achieve reliable absorption, and taking it without an adequate meal substantially reduces exposure and efficacy.
It is metabolised by CYP3A4, so it is contraindicated with potent CYP3A4 inhibitors or inducers and requires dose adjustment with moderate inhibitors; monitor for akathisia, extrapyramidal symptoms and somnolence.
As with all antipsychotics watch for neuroleptic malignant syndrome and avoid in the elderly with dementia-related psychosis owing to increased mortality, though metabolic and prolactin effects are generally less pronounced than with some alternatives.

Monitoring

Monitor mental state, movement disorders and akathisia, weight and metabolic parameters, and for signs of neuroleptic malignant syndrome.

Counselling the patient

Always take this medicine with a substantial meal for it to work properly.
Report restlessness, abnormal movements, muscle stiffness or fever.
Tell your prescriber about other medicines, as some strongly affect lurasidone levels.

Evidence & guidelines

Regulatory approval and NICE-aligned practice support lurasidone for schizophrenia, with product information stressing administration with food for adequate absorption.

Reference: NICE NG178; Maudsley; 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

Drugs

Quetiapine (Elderly — Dementia Caution) · Atypical Antipsychotic

Pathways