Skip to content

Naproxen/Diphenhydramine

    DEA Class;  Rx

    Common Brand Names; Aleve PM

     Analgesics, Other Combos

    Naproxen: Inhibits synthesis of prostaglandins in body tissues by inhibiting at least 2 cyclooxygenase (COX) isoenzymes, COX-1 and COX-2

    Diphenhydramine: Histamine H1-receptor antagonist that elicits sedative effects

    Indicated in Sleeplessness due to Pain

    Hypersensitivity

    Naproxen

    Absolute: Aspirin allergy; perioperative pain in setting of coronary artery bypass graft (CABG) surgery

    Relative: Bleeding disorders, delayed esophageal transit, hepatic disease, peptic ulcer, renal impairment, stomatitis, late pregnancy (may cause premature closure of ductus arteriosus

    Diphenhydramine

    Coadministration with MAOIs

    1-10%

    Naproxen

    • Abdominal pain
    • GI bleeding
    • Nausea
    • Edema
    • Fluid retention

    Diphenhydramine

    • Sedation
    • Anticholinergic effects
    • Xerostomia
    • Blurred vision
    • Palpitations

    In case of overdose, get medical help or contact a Poison Control Center right away

    Not recommmended for patients with likelihood of unrecognized CAD, severe renal impairment (CrCl <30 mL/min), or women who are breast feeding

    Use NSAIDs with caution with underlying cardiovascular disease, active/history of peptic ulcer, inflammatory bowel disease, GI disease, bleeding disorder, renal/hepatic impairment, anemia, asthma, heart failure, edema, dehydration, HTN, or seizure disorder

    Pregnancy

    Use of NSAIDs can cause premature closure of fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment

    Because of these risks, limit dose and duration of use between about 20 and 30 weeks of gestation, and avoid use at about 30 weeks of gestation and later in pregnancy

    Lactation

    Naproxen and diphenhydramine are excreted in human breast milk; effect on infant unknown; not recommended

    Adults

    2 tablets (440mg/50mg) PO at bedtime PRN

    Pediatric

    <12 years: Safety and efficacy not established

    ≥12 years: 2 tablets (440mg/50mg) PO at bedtime PRN

    naproxen/diphenhydramine

    Tablet

    • 220mg/25mg