Pregnancy: In a study in which pregnant rats were given up to 10 mg/kg/day (approximately 8 times the MRHD on a mg/m2 basis) from day 17 of gestation through day 20 postpartum, there was a slight increase in still births and a slight decrease in pup survival through postpartum day 4 at this dose; the next lower dose tested was 3 mg/kg/day. There are no adequate or well-controlled studies in pregnant woman. Use donepezil during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
Lactation: It is not known whether donepezil is excreted in breast milk. Donepezil has no indication for use in breast-feeding mother.