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Intermezzo® (zolpidem tartrate sublingual tablet) is being developed for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. Intermezzo® is a sublingual low dose formulation of zolpidem, the active agent most commonly prescribed in the United States for the treatment of insomnia. Intermezzo® uses approximately one-quarter to one-third of the dose of active drug contained in currently marketed zolpidem-based sleep aids, in a formulation designed to promote rapid sublingual absorption. Transcept received a Complete Response letter from the U.S. Food and Drug Administration (FDA) in July 2011 regarding the resubmission of the Intermezzo® New Drug Application, and is working to resolve issues raised in the letter.
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