Perinatal EvidenceCompass
Prepopulated workbenchMED-161

Wake-promoting/narcolepsy

Modafinil

Wake-promoting or narcolepsy/cataplexy treatment

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
Modafinil
Entity type
single-ingredient drug
Active component(s)
Modafinil
Formulation / route / interval
Oral; formulation varies
Attachment entry
Modafinil
Separate monograph status
No — cross-reference shared molecule monograph
Identity and cross-reference
Also: antidepressant augmentation, off-label ADHD, and stimulant-use-disorder research
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

6 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.

A-059Provisional public source

A Danish registry analysis found a congenital-malformation signal after first-trimester modafinil exposure.

Public-source certainty descriptor
low-to-moderate; concerning but imprecise; not GRADE
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
first trimester
Comparator
modafinil versus methylphenidate and unexposed
Effect or numbers carried forward

6 major malformations among 49 exposed (12%); adjusted OR 3.4 (1.2-9.7) versus methylphenidate and 2.7 (1.1-6.9) versus unexposed.

Limitations

Only 49 exposures, wide intervals, residual confounding, and possible surveillance/selection effects.

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
A-060Provisional public source

A US modafinil/armodafinil pregnancy registry reported a high major-malformation proportion, but voluntary enrollment and absence of an internal comparator severely limit inference.

Public-source certainty descriptor
low; signal-generating; not GRADE
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
first trimester
Comparator
no internal comparator
Effect or numbers carried forward

13 major malformations among 102 prospective live births (13%).

Limitations

Small voluntary registry, live-birth restriction, loss/selection, no internal comparator, and mixed modafinil/armodafinil exposure.

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
A-061Provisional public source

A Scandinavian cohort did not find a modafinil malformation increase, but the estimate was extremely imprecise and does not negate other signals.

Public-source certainty descriptor
very low-to-low; wide interval; not GRADE
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
first trimester
Comparator
modafinil exposed versus unexposed
Effect or numbers carried forward

RR 0.63 (95% CI 0.09-4.40).

Limitations

Small exposed sample and confidence interval compatible with substantial harm or benefit.

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
A-062Provisional public source

The UK MHRA advises that modafinil should not be used in pregnancy, recommends effective contraception during treatment and for two months after stopping, and warns it can reduce steroidal contraceptive effectiveness.

Public-source certainty descriptor
high for UK regulatory position; not a US contraindication
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
preconception and pregnancy
Comparator
not applicable
Effect or numbers carried forward

Contraception advised during treatment and for 2 months after stopping.

Limitations

Jurisdiction-specific; armodafinil inference is related but not identical; individual narcolepsy safety must be addressed.

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
A-063Provisional public source

Single-case lactation reports estimated modest modafinil/armodafinil relative infant doses, but cannot establish infant safety.

Public-source certainty descriptor
very low for infant safety; not GRADE
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
lactation
Comparator
no comparator
Effect or numbers carried forward

Modafinil RID 5.3% in one case; armodafinil RID 4.85% in one case.

Limitations

One case per estimate, uncertain enantiomer accounting, limited infant outcomes, and no long-term follow-up.

Sources, citation controls, and verification state

Linked sources

PMID
30518447
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
A-067Provisional public source

FDA prescription labeling uses narrative Pregnancy and Lactation Labeling Rule sections rather than the former A/B/C/D/X letter categories.

Public-source certainty descriptor
high for US regulatory framework
Formal appraisal
Not started — full text and independent appraisal pending
Exposure window
pregnancy and lactation
Comparator
not applicable
Effect or numbers carried forward

No reliable quantitative estimate.

Limitations

Exact labeling and revision date remain product-specific; non-US systems differ.

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