Transcept Pharmaceuticals Inc. has received the Food and Drug Administration (FDA) approval for its drug Intermezzo - a drug that can help people get back to sleep after waking in the middle of the night. The treatment contains a low-dose of zolpidem tartrate, the active ingredient in Paris-based Sanofi’s sleeping pill Ambien.
Intermezzo was studied in two studies involving more than 370 patients. Patients taking the drug fell back to sleep more quickly than those taking a placebo, or sugar pill. “For people whose insomnia causes them to wake in middle of the night with difficulty returning to sleep, this new medication offers a safer choice than taking a higher dose of zolpidem upon waking,” Robert Temple, deputy center director for clinical science in the FDA’s Center for Drug Evaluation and Research, said in the statement. “With this lower dose there is less risk of a person having too much drug in the body upon waking, which can cause dangerous drowsiness and impair driving.”
Zolpidem, the key ingredient in Ambien was first approved in 1992. This latest FDA's approval for Intermezzo follows two previous rejections 2009 and again in July 2011 citing safety issues. The FDA's concerns centered on the drug's potential side effects the following day, including potential impact on driving.
The company resubmitted its application Sept. 27. Transcept reduced the proposed Intermezzo dosing for women from 3.5 milligrams to 1.75 milligrams in the newest application and revised the instructions to take the drug only if patients have at least four hours of sleep remaining and to refrain from driving for at least one hour after waking, according to a company filing.
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