Fast-Acting Sublingual Zolpidem for Middle-of-the-Night Wakefulness. (5th February 2014)

• Record Type: Journal Article
• Authors: Pergolizzi, Joseph V.; Taylor, Robert; Raffa, Robert B.; Nalamachu, Srinivas; Chopra, Maninder
• Other Names: Pillar Giora Academic Editor.
• Is Part Of: Sleep disorders. Volume 2014(2014)
• Publication Date: 2014-02-05
• Subjects: Sleep disorders -- Periodicals; 616.8498005
• DOI: 10.1155/2014/527109
• Languages: English
• ISSNs: 2090-3545

Abstract

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.