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Sleep Disord. 2014;2014:527109. doi: 10.1155/2014/527109. Epub 2014 Feb 5.

Fast-Acting Sublingual Zolpidem for Middle-of-the-Night Wakefulness.

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1
Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD 21205, USA ; Department of Anesthesiology, Georgetown University School of Medicine, Washington, DC 20057, USA ; Department of Pharmacology, School of Medicine in Philadelphia, Temple University, PA 19140, USA.
2
NEMA Research, Inc., Naples, FL 34108, USA.
3
School of Pharmacy, Temple University, Philadelphia, PA 19140, USA.
4
Kansas University Medical Center, Kansas City, KS 66160, USA ; International Clinical Research, Leawood, KS 66211, USA.
5
Kirax Pharmaceuticals, Bonita Springs, FL 34134, USA.

Abstract

Sleep disorders (somnipathies) are conditions characterized by disruptions of sleep quality or of sleep pattern. They can involve difficulty falling asleep (prolonged sleep onset latency), difficulty staying asleep (disturbance of sleep maintenance), sleep of poor quality (unrefreshing), or combinations of these and can lead to poor health and quality of life problems. A subtype of sleep-maintenance insomnia is middle-of-the-night wakefulness, a relatively common occurrence. Zolpidem, a nonbenzodiazepine benzodiazepine receptor agonist, allosterically modulates an ion channel and increases the influx of Cl(-), thereby dampening the effect of excitatory (sleep disrupting) input. Recently, product label changes to some zolpidem containing products have been implemented by the FDA in order to reduce the risk associated with their morning after residual side effects. A new formulation of zolpidem tartrate (Intermezzo) sublingual tablet, an approved product indicated exclusively for the treatment of middle-of-the-night wakefulness and difficulty returning to sleep, did not have its label changed. We present a short summary of its basic science and clinical attributes in light of the recent regulatory changes for zolpidem products.

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