|
The pharmacokinetics of zolpidem tartrate were studied in 11 patients with end-stage renal failure (mean ClCr=6.5±1.5 mL/min) undergoing hemodialysis three times a week, who were dosed with zolpidem 10 mg orally each day for 14 or 21 days. No statistically significant differences were observed for Cmax, Tmax, half-life, and AUC between the first and last day of drug administration when baseline concentration adjustments were made. On day 1, Cmax was 172±29 ng/mL (range: 46 to 344 ng/mL). After repeated dosing for 14 or 21 days, Cmax was 203±32 ng/mL (range: 28 to 316 ng/mL). On day 1, Tmax was 1.7±0.3 hr (range: 0.5 to 3.0 hr); after repeated dosing Tmax was 0.8±0.2 hr (range: 0.5 to 2.0 hr). This variation is accounted for by noting that last-day serum sampling began 10 hours after the previous dose, rather than after 24 hours. This resulted in residual drug concentration and a shorter period to reach maximal serum concentration. On day 1, T1/2 was 2.4±0.4 hr (range: 0.4 to 5.1 hr). After repeated dosing, T1/2 was 2.5±0.4 hr (range: 0.7 to 4.2 hr). AUC was 796±159 ng·hr/mL after the first dose and 818±170 ng·hr/mL after repeated dosing. Zolpidem was not hemodialyzable. No accumulation of unchanged drug appeared after 14 or 21 days. Ambien (zolpidem tartrate) pharmacokinetics were not significantly different in renally impaired patients. No dosage adjustment is necessary in patients with compromised renal function. As a general precaution, these patients should be closely monitored. Text Continues Below
Postulated relationship between elimination rate of hypnotics and their profile of common untoward effects: The type and duration of hypnotic effects and the profile of unwanted effects during administration of hypnotic drugs may be influenced by the biologic half-life of administered drug and any active metabolites formed. When half-lives are long, drug or metabolites may accumulate during periods of nightly administration and be associated with impairment of cognitive and/or motor performance during waking hours; the possibility of interaction with other psychoactive drugs or alcohol will be enhanced. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
|
.gif)
