Comparative Pharmacology
Head-to-head clinical analysis: ALEVE PM versus VIMOVO.
Peer-Reviewed Evidence
Head-to-head clinical analysis: ALEVE PM versus VIMOVO.
ALEVE PM vs VIMOVO
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.
VIMOVO (esomeprazole and naproxen) is a fixed-dose combination. Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2), decreasing prostaglandin synthesis, thereby reducing inflammation, pain, and fever. Esomeprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by inhibiting the H+/K+ ATPase in gastric parietal cells. The combination is intended to reduce the risk of NSAID-associated gastric ulcers.
1 tablet (220 mg naproxen sodium / 25 mg diphenhydramine HCl) orally at bedtime as needed. Maximum: 2 tablets in 24 hours.
One tablet (naproxen 500 mg/esomeprazole 20 mg) orally twice 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.
Naproxen: 12-17 hours (prolonged in elderly and renal impairment; dosing interval typically 12 hours). Esomeprazole: 1-1.5 hours (metabolized by CYP2C19 and CYP3A4; no accumulation after repeated dosing).
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 50% as naproxen metabolites, <1% unchanged naproxen; less than 1% excreted unchanged in feces as esomeprazole; esomeprazole metabolites excreted in urine 80% and feces 20%.
Category C
Category C
NSAID/Antihistamine Combination
NSAID/PPI Combination