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Doxylamine

UNISOM

Pronunciation: dox-IL-a-meen

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

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.

Doxylamine molecular structure (skeletal formula)
Molecular structure: Doxylamine

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

Available strengths

Pregnancy Undefined

Lactation Undefined

Cost

Doxylamine (UNISOM)
What pharmacies pay · NADAC 9/30/26 · OTC
Strength#/mogeneric $/unitCostPlus
25 mgtabper unit$0.12/eanot offered

NO BOXED WARNINGS

Principal riskAnticholinergic burden and next-day sedation

Classes and tags

Clinical profile

Therapeutic safety burden1 / 4
Overdose danger3 / 4
Weight-gain liability0 / 4
Sedation liability3 / 4
QT / Torsades0 / 4
Direct muscarinic antagonism2 / 4
Embryofetal risk0 / 4

Defining liabilityResidual sedation and antimuscarinic effects

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