POINT RICHMOND, Calif., April 5, 2012 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced today that Intermezzo® (zolpidem tartrate) sublingual tablet CIV is now available by prescription in 1.75 mg and 3.5 mg dosage strengths in retail pharmacies nationwide. Intermezzo is the first and only prescription sleep aid approved for middle-of-the-night dosing, and should only be taken once per night in bed, as needed, when a patient wakes up in the middle of the night and has difficulty returning to sleep. Intermezzo is not indicated for use when a patient has fewer than four hours of bedtime remaining before the planned time of waking.
Intermezzo was developed by Transcept Pharmaceuticals and is the Company's first FDA approved product. Intermezzo is being marketed in the United States under the terms of a collaboration agreement between Transcept and Purdue Pharma L.P."Until today, patients with insomnia did not have an appropriate or FDA approved treatment option to take in the middle of the night because all other prescription sleep aids are approved to be used only at bedtime," said Thomas Roth, Ph.D., Director of Sleep Medicine, Henry Ford Hospital. "Intermezzo represents an important treatment option for those insomnia patients who suffer difficulty falling back to sleep after a middle of the night awakening and seek a sleep aid that they can use only when they really need it to fall back to sleep in the middle of the night." Intermezzo, which was approved by the U.S. Food and Drug Administration in November 2011, is available in spearmint-flavored sublingual tablets that are placed under the tongue and allowed to disintegrate completely before swallowing. Intermezzo contains a bicarbonate-carbonate buffer. On average, Intermezzo is rapidly absorbed in both genders, with a mean time to maximum plasma levels across studies that ranged from about 35 minutes to about 75 minutes. The recommended and maximum dose of Intermezzo is 1.75 mg for female adults and 3.5 mg for male adults, taken only once per night as needed when a middle-of-the-night awakening is followed by difficulty returning to sleep and the patient has at least four hours of bedtime remaining. The recommended doses for women and men are different because women clear zolpidem from the body at a lower rate than men. For optimal effect, Intermezzo should not be administered with or immediately after a meal. "When the insomnia problem is middle-of-the-night awakening followed by difficulty returning to sleep, Intermezzo offers a new treatment strategy that has the potential to make a meaningful difference for many patients," stated Glenn A. Oclassen, President and Chief Executive Officer of Transcept Pharmaceuticals. "Purdue Pharma, our Intermezzo U.S. sales and marketing partner, is firmly committed to helping patients affected by this form of insomnia, and we are confident in their ability to make Intermezzo a commercial success." Important Safety Information Intermezzo is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema.
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