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Dosing and uses of Doxylamine (Unisom)

 

Adult dosage forms and strengths

tablet

  • 25mg

 

Insomnia

25 mg PO qHS PRN 30 min before bedtime

 

Upper Respiratory Tract Allergy

50 mg PO q4-6hr

 

Pediatric dosage forms and strengths

 

Insomnia

<12 years: Not recommended

>12 years: 25 mg PO qHS PRN 30 min before bedtime

 

Geriatric dosage forms and strengths

Avoid use in elderly because of high incidence of anticholinergic effects

Clearance reduced with advanced age, greater risk of confusion, dry mouth, constipation, and other anticholinergic effects and toxicity

May exacerbate existing lower urinary conditions or benign prostatic hyperplasia

Tolerance develops when used as hypnotic

 

Doxylamine (Unisom) adverse (side) effects

Frequency not defined

Minor anticholinergic effects

 

Warnings

Contraindications

Hypersensitivity

 

Cautions

May cause CNS depression, which may impair physical and mental activities

Not to exceed 2 weeks of use

Caution in asthma, glaucoma, enlarged prostate, cardiovascular disease, respiratory disease, or thyroid dysfunction

 

Pregnancy and lactation

Pregnancy category: B

Lactation: excretion in milk unknown

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Doxylamine (Unisom)

Mechanism of action

Competes for H1-receptor sites on target cells; has anticholinergic effects, which depresses labyrinthine function, blocks chemoreceptor trigger zone, and diminishes vestibular stimulation

 

Absorption

Peak Plasma Time: 2-3 hr

Peak Plasma Concentration: 100 ng/mL

 

Elimination

Half-Life: 10-12 hr

Excretion: Urine