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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