Intermezzo® (zolpidem tartrate sublingual tablet), the lead Transcept product candidate, 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.