Pharmacokinetics of Zolpidem from Sublingual Zolpidem Tartrate Tablets In Healthy Elderly Versus Non-Elderly Subjects.
Background: Pharmacokinetic parameters of sedative-hypnotic medications can be influenced by age and gender. Objective: This study analyzed pharmacokinetic parameters of zolpidem, formulated as a sublingual zolpidem tartrate tablet (ZST; Intermezzo®), in healthy elderly males and females (mean age 7...
| Publicado en: | Drugs & Aging Vol. 31; no. 10; pp. 731 - 737 |
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| Autores principales: | , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
Springer Nature
Oct2014
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=103899113&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 103899113 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 1170229X C5B jtl: Drugs & Aging issn: 1170229X maglogo: N pubinfo: dt: Oct2014 vid: 31 iid: 10 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 103899113 98581513 10.1007/s40266-014-0211-3 NLM25246162 103899113 ppf: 731 ppct: 6 formats: fmt: @attributes: type: P tig: atl: Pharmacokinetics of Zolpidem from Sublingual Zolpidem Tartrate Tablets In Healthy Elderly Versus Non-Elderly Subjects. aug: au: Greenblatt, David Harmatz, Jerold Singh, Nikhilesh Steinberg, Frank Roth, Thomas Harris, Stephen Kapil, Ram affil: Department of Integrative Physiology and Pathobiology, Tufts University School of Medicine, 136 Harrison Avenue Boston 02111 USA sug: subj: Zolpidem Pharmacokinetics Administration, Sublingual Methods Human Randomized Controlled Trials Aged Crossover Design T-Tests Paired T-Tests Funding Source Aged: 65+ years ab: Background: Pharmacokinetic parameters of sedative-hypnotic medications can be influenced by age and gender. Objective: This study analyzed pharmacokinetic parameters of zolpidem, formulated as a sublingual zolpidem tartrate tablet (ZST; Intermezzo®), in healthy elderly males and females (mean age 72 years) and in non-elderly males and females (34 years). Methods: This was a randomized, single-dose, open-label, two-way crossover study evaluating pharmacokinetic parameters of 1.75 and 3.5 mg dosages of ZST in elderly subjects ( n = 22), and 3.5 mg dosages of ZST in non-elderly subjects ( n = 24). Main outcome measures were pharmacokinetic parameters, including area under the plasma concentration-time curve (AUC), maximum observed concentration ( C), time to reach C ( T), elimination half-life ( T), and apparent oral clearance (CL/F). Results: Dose proportionality in zolpidem exposure was maintained between 1.75 and 3.5 mg doses for both elderly females and males. With administration of the 3.5 mg dose of ZST to elderly and non-elderly subjects, significantly higher systemic exposure was seen in elderly females ( C +44.6 %, P < 0.01; AUC +40.4 %) compared with non-elderly females. However, systemic exposure was only modestly higher in elderly males compared with non-elderly males. Greater exposure was seen in elderly females compared to males ( C +46.8 %, P < 0.01; AUC +31.4 %). In this study, exposure between non-elderly females and males was equivalent. Changes in T and T values were not observed, with no significant age effect on oral clearance. There were no apparent differences in tolerability among age and gender groups. Conclusion: Elderly individuals were found to have higher C and AUC values compared with non-elderly subjects. C and AUC were greater in elderly women compared with elderly men. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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