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Doxylamine

UNISOM

What it isFirst-generation H1 antagonist; insomnia, and with pyridoxine for nausea of pregnancy.

Why this oneThe pyridoxine combination is the only FDA-approved treatment for nausea and vomiting of pregnancy.

What limits itAnticholinergic burden and next-day sedation. Tolerance to the hypnotic effect develops quickly.

FDA-approved for

FDA label

FDA dosingPopulationStartTargetMax
Insomnia (OTC nighttime sleep aid)Adults & children ≥12 y1 tablet QHS PRN1 tablet QHS1 tablet/day

Renal Undefined

Hepatic Undefined

Instructions

Pregnancy Undefined

Lactation Undefined

NO BOXED WARNINGS

Principal riskAnticholinergic burden and next-day sedation

Classes and tags

Clinical profile

Direct muscarinic antagonism2 / 4

Mechanism of action: Doxylamine ballicule

Doxylamine ballicule: receptor binding, kinetics and half-life diagram

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