Perinatal EvidenceCompass
Prepopulated workbenchMED-114

Antipsychotics — fixed combinations

Olanzapine/samidorphan

Schizophrenia and bipolar I disorder

Brand / product examples: Lybalvi

Not a categorical safety rating

This record organizes questions; it does not close them.

The clinical fields and position statements are prepopulated from the public-source corpus. They have not completed individual dual extraction, formal appraisal, exact-label reconciliation, or multidisciplinary sign-off. Do not use this page to justify abrupt discontinuation or reflexive switching.

Inventory identity

What this record represents

Canonical generic name
Olanzapine/samidorphan
Entity type
fixed-dose combination
Active component(s)
Olanzapine · samidorphan
Formulation / route / interval
Oral; formulation varies
Attachment entry
Olanzapine/samidorphan
Separate monograph status
Yes — fixed combination plus both component cross-references
Identity and cross-reference
Cross-reference olanzapine and samidorphan
Inventory verification confidence
Moderate — molecule-level source; exact product/jurisdiction pending

Decision taxonomy

Five positions kept separate

These are workbench statements for reviewer execution. They are not independently commissioned, patient-specific recommendations.

  1. 01

    Stable continuation

    Workbench statement

    Do not withhold or discontinue solely because of pregnancy or lactation. For this record, assess indication, prior response, relapse severity, dose/formulation, alternatives, exposure timing, and mapped evidence; individual commissioned adjudication remains pending.

  2. 02

    New initiation in pregnancy

    Workbench statement

    For a new start, prefer an effective option with the strongest diagnosis-specific efficacy and reproductive evidence when clinically suitable. This record has not received an individual, independently verified initiation ranking.

  3. 03

    Switch before conception

    Workbench statement

    Before conception, consider a switch only when expected benefit exceeds relapse, withdrawal, failed-switch, and dual-exposure risks. Build and monitor the plan before pregnancy when feasible; no universal switch direction is assigned here.

  4. 04

    Unplanned exposure

    Workbench statement

    After unplanned exposure, confirm product, route, dose, timing, indication, co-exposures, and symptoms; do not advise abrupt cessation. Use the mapped evidence and current label to decide whether any targeted fetal assessment is indicated.

  5. 05

    Delivery, postpartum & lactation

    Workbench statement

    Create separate delivery, postpartum-dose, neonatal-observation, and lactation plans. Do not infer breastfeeding suitability from pregnancy evidence or routinely taper before delivery without drug-specific support.

Linked evidence

5 mapped claim summaries

Mapping can include class-wide, framework, formulation, regulatory, or evidence-gap claims. A linked claim is not necessarily a drug-specific causal estimate.

B-038Provisional public source

Neonatal EPS or withdrawal/adaptation signs have been reported after third-trimester antipsychotic exposure.

Public-source certainty descriptor
regulatory class warning; absolute risk unknown
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
third trimester/near delivery
Comparator
no late antipsychotic exposure
Effect or numbers carried forward

Reported signs include agitation, hypertonia or hypotonia, tremor, somnolence, respiratory distress, and feeding disorder; severity and duration vary, and no reliable incidence is available.

Limitations

Spontaneous reports, co-medications, illness severity, and no reliable denominator; Cobenfy is mechanistically distinct and excluded from this class claim.

Sources, citation controls, and verification state

Linked sources

PMID
Not populated in v0.95
DOI
Pending DOI verification
Exact locator
Pending exact table/figure/page/supplement locator
Access date
2026-07-29
Integrity check
Same-day source surveillance recorded; source-by-source correction/retraction verification remains pending
Internal verification
Source-linked; independent external verification pending
B-056Evidence gap

Fixed antipsychotic combinations require component-by-component and product-specific assessment; olanzapine evidence alone is insufficient.

Public-source certainty descriptor
very low—combination-specific evidence
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
pregnancy and lactation
Comparator
separately titrated components
Effect or numbers carried forward

No combination-specific comparative pregnancy estimate

Limitations

Component cohorts cannot detect interaction effects or fixed-ratio consequences.

Sources, citation controls, and verification state

Linked sources

PMID
Not populated in v0.95
DOI
Pending DOI verification
Exact locator
Pending exact table/figure/page/supplement locator
Access date
2026-07-29
Integrity check
Same-day source surveillance recorded; source-by-source correction/retraction verification remains pending
Internal verification
Source-linked; independent external verification pending
B-057Provisional public source

Samidorphan can precipitate severe opioid withdrawal in opioid-dependent patients and complicate opioid analgesia around delivery.

Public-source certainty descriptor
regulatory label
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
initiation, emergency analgesia, labor/delivery
Comparator
olanzapine without samidorphan
Effect or numbers carried forward

Severe withdrawal risk and opioid blockade; product-specific opioid-free intervals apply

Limitations

No pregnancy-specific comparative trial; opioid history may be incompletely disclosed.

Sources, citation controls, and verification state

Linked sources

PMID
Not populated in v0.95
DOI
Pending DOI verification
Exact locator
Pending exact table/figure/page/supplement locator
Access date
2026-07-29
Integrity check
Same-day source surveillance recorded; source-by-source correction/retraction verification remains pending
Internal verification
Source-linked; independent external verification pending
B-063Provisional public source

A stable patient should not be switched reflexively after conception solely to use a medicine with more pregnancy data.

Public-source certainty descriptor
guideline recommendation
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
after conception
Comparator
continuing an effective regimen
Effect or numbers carried forward

No single effect estimate; relapse and fetal polypharmacy tradeoff

Limitations

Important exceptions include valproate and compelling toxicity/ineffectiveness; individual history controls the decision.

Sources, citation controls, and verification state
PMID
Not populated in v0.95
DOI
Pending DOI verification
Exact locator
Pending exact table/figure/page/supplement locator
Access date
2026-07-29
Integrity check
Same-day source surveillance recorded; source-by-source correction/retraction verification remains pending
Internal verification
Source-linked; independent external verification pending
B-064Provisional public source

If an antipsychotic was effective throughout pregnancy, routine postpartum switching solely for lactation is usually discouraged.

Public-source certainty descriptor
guideline recommendation
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
postpartum/lactation
Comparator
switching to a different agent
Effect or numbers carried forward

No single effect estimate

Limitations

Clozapine, milk-supply goals with aripiprazole, infant prematurity/illness, and long-lived/LAI exposure may change the decision.

Sources, citation controls, and verification state
PMID
Not populated in v0.95
DOI
Pending DOI verification
Exact locator
Pending exact table/figure/page/supplement locator
Access date
2026-07-29
Integrity check
Same-day source surveillance recorded; source-by-source correction/retraction verification remains pending
Internal verification
Source-linked; independent external verification pending