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Intermezzo® (zolpidem tartrate sublingual tablet) is a sublingual low dose formulation of zolpidem that has been developed for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. On September 30, 2008, Transcept submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval to market Intermezzo® in the United States. The FDA issued a Complete Response Letter regarding the New Drug Application for Intermezzo® on October 28, 2009, and Transcept is working to respond to the issues raised in the Complete Response Letter.
Middle of the Night Awakening
Based on a recently published study of nearly 9,000 individuals, the Stanford Sleep Epidemiology Research Center has estimated that about one-third of adults in the United States experience middle of the night awakenings at least three times each week. The study concluded that more than 90% of those subjects who reported middle of the night awakenings reported that this insomnia symptom persisted for at least six months, and that fewer than 25% of the middle of the night awakening group reported difficulty going to sleep at bedtime. The 2005 Yankelovich Health Behaviors Study indicated that 11% of U.S. population age 18 and older describe their pattern of middle of the night awakenings as producing a moderate to severe impact on their lives.
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Products in Development
