Zolpidem tartrate (Intermezzo) The venous blood from the sublingual region of the oral cavity drains into a common trunk, which then drains.
Lipids present in the oral mucous membrane offer the main barrier to the permeability of hydrophilic drugs. Non-polar molecules cross through the lipid regions of the epithelium, while polar molecules travel through ionic channels present in the intercellular spaces of the epithelium, or aqueous pores present in the epithelial cells. Thus, the potential transport path across the oral mucous membrane may be either polar or non-polar. For this reason, an understanding of a drug’s lipophilic or hydrophilic nature during the developmental stage of the drug product appears to be the most useful index for evaluating its suitability for absorption across the oral mucosa.
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The primary objective of the present study was to evaluate the efficacy of single doses of sublingual zolpidem (5 and 10mg) versus oral.
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Twenty-one healthy volunteers included in this study were recorded by polysomnography during 2 consecutive nights and, on the day in between, during a 2h nap. Eighteen out of these 21 subjects were finally analyzed. Treatment was randomly administered before the second recording night to subjects demonstrating at least 30min of sleep during the nap recording.
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OX22 is zolpidem formulated for sublingual administration. The primary objective of the present study was to evaluate the efficacy of single doses of sublingual zolpidem (5 and 10mg) versus oral zolpidem (10mg), with regard to latency to persistent sleep (LPS), in a post-nap model of insomnia.
The present results show that OX22, a sublingual formulation of zolpidem, has a significant earlier sleep initiation as compared to an equivalent dose of oral zolpidem in healthy volunteers in a post-nap model of insomnia.
Contrast analyses show that 10mg OX22 significantly shortened LPS compared to oral zolpidem administration of 10mg (12.8+/-9.9 and 18.4+/-11.3min, respectively; p<.05). No treatment effects could be evidenced on total sleep time, time awake after sleep onset and sleep architecture parameters for OX22 compared to oral zolpidem. All treatments were well tolerated and did not induce next-day residual effects.
Abstract: BACKGROUND: A zolpidem sublingual tablet (ZST) formulation was of zolpidem buffered sublingual tablet and zolpidem oral immediate-release respectively, in females and 18 vs 10 ng/mL in males) and AUCs from zero to 15.
See Clin Ther. This article has been corrected. 2013 Jun;35(6):900.
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