Low dose famotidine in the prevention of sleep disturbance caused by heartburn after an evening meal.

Author(s): Mann SG, Murakami A, McCarroll K, Rao AN, Cottrell J, Mehentee J, Morton R

Affiliation(s): Medical, Regulatory and Technical Group, J&J MSD Europe, High Wycombe, Buckinghamshire, UK.

Publication date & source: 1995-08, Aliment Pharmacol Ther., 9(4):395-401.

Publication type: Clinical Trial; Randomized Controlled Trial

AIM: To determine whether, in a susceptible population, dosing with 10 mg famotidine 1 h before an evening meal could decrease the interference with sleep caused by heartburn. METHODS: Patients with a history of frequent heartburn (n = 309) were randomized to receive 10 mg famotidine or placebo 1 h before an evening meal likely to induce symptoms. Patients assessed the efficacy of the treatment in preventing heartburn after the meal, at bedtime and during the night. The number of awakenings due to heartburn and the consumption of antacid tablets taken to alleviate symptoms were also recorded. RESULTS: Treatment groups were well matched and data from 302 patients were available for analysis. Compared to placebo, famotidine treated patients had: less heartburn after the meal (P < 0.0001 mean global scores), less interference with getting to sleep (P = 0.0156 mean global scores), fewer awakenings (P = 0.0001 difference in mean number) and better control of heartburn during the night (P < 0.0001 mean global scores). They were also almost three times less likely to need antacid treatment than the placebo group during the night (relative odds for no antacid 2.78 (95% CI: 1.29-5.96). Only four patients in each group suffered adverse events. CONCLUSION: Taking a 10 mg dose of famotidine 1 h before an evening meal appears to be a successful and well tolerated strategy for preventing post-prandial heartburn and avoiding the associated interference with sleep.