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Ambien is converted to inactive metabolites that are eliminated primarily by renal excretion. Ambien demonstrated linear kinetics in the dose range of 5 to 20 mg. Total protein binding was found to be 92.5±0.1% and remained constant, independent of concentration between 40 and 790 ng/mL. Zolpidem did not accumulate in young adults following nightly dosing with 20-mg zolpidem tartrate tablets for 2 weeks. A food-effect study in 30 healthy male volunteers compared the pharmacokinetics of Ambien 10 mg when administered while fasting or 20 minutes after a meal. Results demonstrated that with food, mean AUC and Cmax were decreased by 15% and 25%, respectively, while mean Tmax was prolonged by 60% (from 1.4 to 2.2 hr). The half-life remained unchanged. These results suggest that, for faster sleep onset, Ambien should not be administered with or immediately after a meal. In the elderly, the dose for Ambien should be 5 mg (see Precautions and Dosage and Administration). This recommendation is based on several studies in which the mean Cmax, T1/2, and AUC were significantly increased when compared to results in young adults. In one study of eight elderly subjects (>70 years), the means for Cmax, T1/2, and AUC significantly increased by 50% (255 vs 384 ng/mL), 32% (2.2 vs 2.9 hr), and 64% (955 vs 1,562 ng·hr/mL), respectively, as compared to younger adults (20 to 40 years) following a single 20-mg oral zolpidem dose. Ambien did not accumulate in elderly subjects following nightly oral dosing of 10 mg for 1 week. Text Continues Below
The pharmacokinetics of Ambien in eight patients with chronic hepatic insufficiency were compared to results in healthy subjects. Following a single 20-mg oral zolpidem dose, mean Cmax and AUC were found to be two times (250 vs 499 ng/mL) and five times (788 vs 4,203 ng·hr/mL) higher, respectively, in hepatically compromised patients. Tmax did not change. The mean half-life in cirrhotic patients of 9.9 hr (range: 4.1 to 25.8 hr) was greater than that observed in normals of 2.2 hr (range: 1.6 to 2.4 hr). Dosing should be modified accordingly in patients with hepatic insufficiency (see Precautions and Dosage and Administration). Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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