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Sleep Disorders
Volume 2014, Article ID 527109, 9 pages
Review Article

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

1Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD 21205, USA
2Department of Anesthesiology, Georgetown University School of Medicine, Washington, DC 20057, USA
3Department of Pharmacology, School of Medicine in Philadelphia, Temple University, PA 19140, USA
4NEMA Research, Inc., Naples, FL 34108, USA
5School of Pharmacy, Temple University, Philadelphia, PA 19140, USA
6Kansas University Medical Center, Kansas City, KS 66160, USA
7International Clinical Research, Leawood, KS 66211, USA
8Kirax Pharmaceuticals, Bonita Springs, FL 34134, USA

Received 18 March 2013; Revised 2 November 2013; Accepted 2 November 2013; Published 5 February 2014

Academic Editor: Giora Pillar

Copyright © 2014 Joseph V. Pergolizzi Jr. et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


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.