Comparative Pharmacology
Head-to-head clinical analysis: ALEVE PM versus NAPROSYN.
Peer-Reviewed Evidence
Head-to-head clinical analysis: ALEVE PM versus NAPROSYN.
ALEVE PM vs NAPROSYN
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Diphenhydramine is a histamine H1 receptor antagonist that competes with histamine for binding at H1 receptor sites, reducing symptoms of allergic reactions and causing sedation. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes, decreasing synthesis of prostaglandins, which reduces pain and inflammation.
Nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing prostaglandin synthesis. This results in decreased inflammation, pain, and fever.
1 tablet (220 mg naproxen sodium / 25 mg diphenhydramine HCl) orally at bedtime as needed. Maximum: 2 tablets in 24 hours.
250-500 mg orally twice daily; maximum 1500 mg/day. For extended-release: 750-1000 mg orally once daily.
None Documented
None Documented
Naproxen: 12-17 hours (mean 13.6 hours); sufficient for twice-daily dosing; prolonged in renal impairment. Diphenhydramine: 2.4-9.3 hours (mean 5.5 hours); longer in elderly, hepatic impairment.
Terminal elimination half-life is 12-17 hours. This long half-life allows twice-daily dosing, but may lead to drug accumulation in elderly or renally impaired patients.
Naproxen: renal (95% as unchanged drug and metabolites, primarily as naproxen and 6-O-desmethyl naproxen). Diphenhydramine: renal (50-60% as unchanged drug and metabolites, primarily as diphenhydramine and nor diphenhydramine); small amounts in feces.
Renal excretion of conjugated metabolites accounts for approximately 95% of a dose, with 1-2% as unchanged naproxen. Fecal excretion is minimal (<5%).
Category C
Category C
NSAID/Antihistamine Combination
NSAID