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Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nonteratogenic effects: Studies to assess the effects on children whose mothers took zolpidem during pregnancy have not been conducted. However, children born of mothers taking sedative/hypnotic drugs may be at some risk for withdrawal symptoms from the drug during the postnatal period. In addition, neonatal flaccidity has been reported in infants born of mothers who received sedative/hypnotic drugs during pregnancy. Text Continues Below
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. Page: << Prev | 1 | 2 | 3 | 4 | 5
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