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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Greenblatt, David J. Harmatz, Jerold S. Singh, Nikhilesh N. Steinberg, Frank Roth, Thomas Moline, Margaret L. Harris, Stephen C. Kapil, Ram P. |
| Description | Country affiliation: United States Author Affiliation: Greenblatt DJ ( Department of Integrative Physiology and Pathobiology, Tufts University School of Medicine, Boston, MA, USA.) |
| Abstract | The effect of dose and gender on the pharmacokinetics (PK) and pharmacodynamics (PD) of zolpidem after administration of a buffered zolpidem sublingual tablet (ZST; Intermezzo®, Purdue Pharma L.P., Stamford, CT, USA) was evaluated in healthy non-elderly male and female volunteers. Subjects received a single morning dose of ZST (1.0, 1.75, and 3.5 mg) or placebo in a four-way crossover study. In male and female subjects zolpidem PK were linear, with area under the curve (AUC) proportional to dose, and apparent oral clearance and elimination half-life independent of dose. However, AUC averaged 40% to 50% higher in females than in males receiving the same dose. The gender effect was incompletely explained by body weight. In females, ZST produced PD changes consistent with benzodiazepine agonist effects, particularly at the 3.5-mg dose. For several PD variables, PD effects were significantly related to plasma zolpidem concentrations when data were aggregated across subjects. However, there was variability in response among individuals. In males, PD effects of zolpidem seldom differed from placebo regardless of plasma concentration. The findings confirm that zolpidem clearance is lower in females than in males. PD effects of zolpidem from ZST are greater in female subjects, due to a combination of higher plasma concentrations and greater intrinsic sensitivity. |
| File Format | HTM / HTML |
| ISSN | 00912700 |
| Issue Number | 3 |
| Volume Number | 54 |
| e-ISSN | 15524604 |
| Journal | The Journal of Clinical Pharmacology |
| Language | English |
| Publisher | Wiley |
| Publisher Date | 2014-03-01 |
| Publisher Place | Great Britain (UK) |
| Access Restriction | One Nation One Subscription (ONOS) |
| Subject Keyword | Discipline Pharmacology Hypnotics And Sedatives Pharmacology Pharmacokinetics Pyridines Administration, Sublingual Adult Cross-over Studies Double-blind Method Female Humans Administration & Dosage Blood Male Middle Aged Sex Characteristics Young Adult Journal Article Randomized Controlled Trial Research Support, Non-u.s. Gov't |
| Content Type | Text |
| Resource Type | Article |
| Subject | Pharmacology Pharmacology (medical) |
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