Ambien - Warnings & Precautions

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Labor and delivery:

Ambien (zolpidem tartrate) has no established use in labor and delivery.

Nursing mothers:

Studies in lactating mothers indicate that the half-life of zolpidem is similar to that in young normal volunteers (2.6±0.3 hr). Between 0.004 and 0.019% of the total administered dose is excreted into milk, but the effect of zolpidem on the infant is unknown.

In addition, in a rat study, zolpidem inhibited the secretion of milk. The no-effect dose was 4 mg base/kg or 6 times the recommended human dose in mg/m2.

The use of Ambien in nursing mothers is not recommended.

Pediatric use: Safety and effectiveness in pediatric patients below the age of 18 have not been established.

Geriatric use:

A total of 154 patients in U.S. controlled clinical trials and 897 patients in non-U.S. clinical trials who received zolpidem were 60 years of age. For a pool of U.S. patients receiving zolpidem at doses of 10 mg or placebo, there were three adverse events occurring at an incidence of at least 3% for zolpidem and for which the zolpidem incidence was at least twice the placebo incidence (ie, they could be considered drug related).

Adverse Event Zolpidem Placebo

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Dizziness 3% 0%

Drowsiness 5% 2%

Diarrhea 3% 1%

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A total of 30/1,959 (1.5%) non-U.S. patients receiving zolpidem reported falls, including 28/30 (93%) who were 70 years of age. Of these 28 patients, 23 (82%) were receiving zolpidem doses >10 mg. A total of 24/1,959 (1.2%) non-U.S. patients receiving zolpidem reported confusion, including 18/24 (75%) who were 70 years of age. Of these 18 patients, 14 (78%) were receiving zolpidem doses >10 mg.