FDA supply Complete Response Letter for Intermezzo

The FDA has sent out a Complete Response Letter to Transcept Pharma regarding its resubmitted New Drug Application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet) for Sleeping Disorders. In its Complete Response Letter, the FDA confirmed that the company has adequately demonstrated that Intermezzo is efficacious for use in treating insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. However, the FDA states that it cannot conclude that Intermezzo can be used safely based on the information in the NDA. The proposed label for Intermezzo indicates that the drug should only be taken when patients have at least four hours of bedtime remaining before being active again.