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Last updated on April 16, 2014 at 1:21 EDT

Latest zolpidem Stories

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2009-01-16 06:55:00

Need the help of a pill to catch some zzz's? According to a new study you're not alone; the use of prescription sleep aids nearly tripled among young adults between 1998 and 2006."Insomnia, a condition traditionally associated with older adults, appears to be causing larger numbers of young adults to turn to prescription sleep aids, and to depend on them for longer periods of time," said William Marder, senior vice president and general manager for the healthcare business of Thomson Reuters,...

2008-12-16 08:00:00

FDA to review Intermezzo(R) (zolpidem tartrate sublingual lozenge) as the first sleep aid specifically designed for the treatment of middle-of-the-night awakenings PT. RICHMOND, Calif., Dec. 16 /PRNewswire/ -- Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced today that it has received confirmation from the U.S. Food and Drug Administration (FDA) that the New Drug Application (NDA) for Intermezzo(R) (zolpidem tartrate sublingual lozenge) has been...

2008-12-01 08:00:00

PT. RICHMOND, Calif., Dec. 1 /PRNewswire/ -- Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced today that Glenn A. Oclassen, President & Chief Executive Officer, is scheduled to participate at the RBC Capital Markets 2008 Healthcare Conference in New York City on a panel entitled "Delivering Novel Drug Solutions: The Future of Drug Delivery." This presentation is scheduled to take place on Thursday, December 11, 2008 at 1:30 PM Eastern...

2008-10-22 09:00:42

PT. RICHMOND, Calif., Oct. 22 /PRNewswire/ -- Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced today that a Phase 3 study evaluating the safety and efficacy of its lead product candidate, Intermezzo(R) (zolpidem tartrate sublingual lozenge), has been published in the September 2008 issue of SLEEP, a publication of the Associated Professional Sleep Societies. Intermezzo(R) is a low dose, buffered, sublingual formulation of zolpidem intended to be...

2008-10-08 09:00:50

PT. RICHMOND, Calif., Oct. 8 /PRNewswire/ -- Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced today that Thomas P. Soloway, Senior Vice President and Chief Financial Officer, is scheduled to present at the Natixis Bleichroeder Second Annual Hidden Gems Conference in New York City on Monday, October 13, 2008 at 9:30 AM Eastern Time. An audio webcast of the presentation will be available at http://www.wsw.com/webcast/nblr2/transcept/ and on the...

2008-09-19 09:00:40

NovaDel Pharma, a specialty pharmaceutical company, has announced that the FDA has requested an extension of up to three months on the Prescription Drug User Fee Act deadline in order to complete the review of the company's Zolpimist oral spray for the short-term treatment of insomnia. Based on the original Prescription Drug User Fee Act (PDUFA) date for Zolpimist, the FDA will reply on or before December 19, 2008. NovaDel submitted its Zolpimist application using the FDA's 505(b)(2)...

2008-09-18 18:00:19

NovaDel Pharma Inc. (AMEX: NVD) today announced that the U.S. Food and Drug Administration (FDA) has requested an extension of up to 3 months on the Prescription Drug User Fee Act (PDUFA) deadline in order to complete the review of the Company's Zolpimist (zolpidem tartrate) Oral Spray for the short-term treatment of insomnia. Based on the original PDUFA date for Zolpimist, the FDA will reply on or before December 19, 2008. "We believe we have submitted a high quality 505(b)(2) application...

2008-09-02 03:00:33

Novacea, Inc. (NASDAQ: NOVC) and Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced today that they have entered into a definitive merger agreement under which Novacea will merge with Transcept in an all-stock transaction. Under the terms of the merger agreement, Novacea will issue new shares of its common stock to Transcept stockholders based on an exchange ratio to be determined prior to the closing of the transaction. Under the exchange ratio...

2008-08-18 15:05:00

SAN DIEGO, Aug. 18 /PRNewswire/ -- The next time you consider popping a pill when you have trouble nodding off, it might be worth counting sheep instead. A senior psychiatrist at the Scripps Clinic Sleep Center in San Diego, Calif. has found evidence that taking sleeping pills regularly can increase the risk of skin cancer. Daniel F. Kripke, M.D.'s article, based on a compilation of studies involving sleeping pills and cancer, has just been published in the Journal of Sleep Research. It...

2008-07-29 03:01:19

Regulatory News: The submitted registration application for Sublinox has been accepted by the FDA as complete for substantive review after initial evaluation. Sublinox contains the well-known active substance zolpidem and is based on Orexo's sublingual technology, involving a rapidly disintegrating tablet placed under the tongue. Meda AB acquired the exclusive world-wide commercialization rights for Sublinox on April 14, 2008. "This FDA's acceptance increases the chances for a...