Doxylamine

Brands

DEA Class; OTC

Common Brand Names; Unisom

  • Sedative/Hypnotics; 
  • Antihistamines, Ethanolamine Derivatives

Oral first-generation, sedating antihistamine; significant sedative action and anticholinergic effects
Primarily used as a single agent in adults for short-term nonprescription (OTC) treatment of insomnia
Also available in products for allergy and cold symptoms in adult and pediatric patients 6 years of age and older

Indicated for the short-term treatment of insomnia (less than 2 weeks).
For the treatment of symptoms associated with allergic rhinitis, including rhinorrhea, sneezing, itching of the nose or throat, or itchy/watery eyes.
 

Hypersensitivity

Children <12 years

Coadministration with any other product containing doxylamine

  • Tachycardia
  • Dysuria
  • Urinary retention
  • Palpitations
  • Constipation
  • Diarrhea
  • Epigastric pain
  • Xerostomia
  • Anorexia
  • Dizziness
  • Drowsiness
  • Blurred vision
  • Vertigo
  • Paradoxical CNS stimulation
  • Disorientation
  • Diplopia

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

Use with caution in patients with increased intraocular pressure or angle closure glaucoma

Not for use to treat insomnia in children <12 years; may cause paradoxical excitation in young children

CNS effects may be potentiated when used with other sedative drugs or ethanol

Not for use unless patient has enough time for a full night’s sleep

Ask healthcare professional before use if taking sedative or any other sleep-aid, tranquilizers, any other antihistamines, any other drugs

When using this product avoid alcoholic beverages, do not drive a motor vehicle or operate machinery, take only at bedtime

Pregnancy Category: B

Lactation: excretion in milk unknown

Adults

25 mg/day PO for insomnia; 60 mg/day for allergic rhinitis.

Geriatric

25 mg/day PO for insomnia; 60 mg/day PO for allergic rhinitis.

Adolescents

25 mg/day PO for insomnia; 60 mg/day PO for allergic rhinitis.

Children

12 years: 25 mg/day PO for insomnia; 60 mg/day PO for allergic rhinitis.
6 to 11 years: 30 mg/day PO for allergic rhinitis.
Less than 6 years: Safety and efficacy have not been established.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Doxylamine succinate

tablet

  • 25mg
Drugs Generic
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