title: Pharmacokinetics and pharmacodynamics of zolpidem following repeated doses in hemodialyzed uraemic patients.
abstract: Zolpidem, an imidazopyridine derivative, is a chemically novel, non-benzodiazepine hypnotic agent. Many uraemic patients complain of sleep disorders and ask for hypnotic medication which is well tolerated both clinically and biologically in such patients. We studied the pharmacokinetics and pharmacodynamics of zolpidem in 12 end-stage renal patients regularly treated by hemodialysis three times a week. Zolpidem (10 mg) was given orally for 14 or 21 days. Pharmacokinetic and pharmacodynamic evaluations were repeated at the end of the study on day 14 or day 21. Cmax, Tmax, t1/2 and the area under the curve were not modified in hemodialyzed patients. After daytime dosing, zolpidem induced the same level of sleepiness after the first and last dose and was well tolerated as a hypnotic agent after the night-time dosing. From these results, it can be said that zolpidem may be administered safely to patients with severe renal impairment without any modification of the dosage regimen.
authors.affiliation: Hôpital de Bois-Guillawne, France.
authors.forename: J P
authors.initials: JP
authors.lastname: Fillastre
authors.forename: S
authors.initials: S
authors.lastname: Geffroy-Josse
authors.forename: I
authors.initials: I
authors.lastname: Etienne
authors.forename: M
authors.initials: M
authors.lastname: Dhib
authors.forename: P
authors.initials: P
authors.lastname: Rosenzweig
authors.forename: P
authors.initials: P
authors.lastname: Danjou
authors.forename: C
authors.initials: C
authors.lastname: Dubruc
authors.forename: G
authors.initials: G
authors.lastname: Bianchetti
mesh_terms: D000328:Adult; D000368:Aged; D001143:Arousal / Q000187:drug effects; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D003404:Creatinine / Q000652:urine; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000494:pharmacology*; D008297:Male; D008875:Middle Aged; D011725:Pyridines / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000494:pharmacology*; D006435:Renal Dialysis; D012890:Sleep / Q000187:drug effects; D013050:Spectrometry, Fluorescence; D014511:Uremia / Q000378:metabolism*; D000077334:Zolpidem
chemical_list: D006993:Hypnotics and Sedatives; D011725:Pyridines; D000077334:Zolpidem; D003404:Creatinine