👶Pregnancy
In combination with pyridoxine, doxylamine is commonly used for pregnancy-associated nausea and vomiting and has not been shown to increase baseline risk of major birth defects. For insomnia in pregnancy, behavioral approaches and safer pharmacologic options are generally preferred—discuss with OB and psychiatry.🤱Breastfeeding
Doxylamine is expected to appear in breast milk. Infants may experience irritability, unusual sleepiness, or feeding difficulties. Use the lowest effective dose for the shortest time if needed and monitor the infant for sedation, poor feeding, or breathing concerns.👧Children & Adolescents (Under 18)
Insomnia: 25 mg PO once nightly for ages ≥12 years when recommended by a health care professional. Do not use in children <12 years for sleep. Children are more prone to paradoxical excitation.👴Older Adults (65+)
Beers Criteria recommend avoiding doxylamine in adults ≥65 years due to strong anticholinergic effects, reduced clearance, and increased risk of confusion, falls, and dementia. Consider non-drug treatments and safer alternatives.🔬Liver Impairment
No dose adjustment recommendations in labeling; consider starting cautiously in hepatic impairment.💧Kidney Impairment
Excreted in urine as parent drug and metabolites; use caution in severe renal impairment and monitor for prolonged sedation.