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Latest Hypnotics Stories

2009-11-23 15:05:00

POINT RICHMOND, Calif., Nov. 23 /PRNewswire-FirstCall/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) today announced that it is scheduled to meet with the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). As previously announced, the Complete Response Letter, received by Transcept on October 28, 2009, indicated that the FDA...

2009-10-29 00:13:00

RICHMOND, Calif., Oct. 29 /PRNewswire-FirstCall/ -- Transcept Pharmaceuticals (Nasdaq: TSPT) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). The NDA, submitted by Transcept in September 2008, seeks approval to market Intermezzo® for use as-needed for the treatment of insomnia when a middle of the night...

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2009-10-23 06:50:00

U.S. drug labels often omit key information about a medicine's effectiveness and the severity of its side effects, according to a commentary written by two doctors in the New England Journal of Medicine. Such omission of data can result in some medicines appearing safer and more effective than they actually are, wrote Drs. Lisa Schwartz and Steven Woloshin of the Dartmouth Institute for Health Policy and Clinical Practice in Hanover, New Hampshire. "The most direct way that the FDA...

2009-10-22 06:00:00

REDWOOD CITY, Calif., Oct. 22 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. today announced positive results from a Phase 2 clinical trial of ARX-03, a proprietary sublingual dosage form combining an opioid, sufentanil, with a benzodiazepine, triazolam. ARX-03 is designed to address the current unmet need for a non-invasive product to provide mild sedation, anxiolysis and analgesia with rapid onset of action for the increasing number of painful and anxiety-producing office-based...

2009-10-20 18:51:02

Researchers say antiepilectic drug treatments administered when the brain is developing appear to trigger schizophrenia-like behavior in animal models. In humans, having a history of seizures in infancy is a significant risk factor for development of schizophrenia later in life, but it is not known whether the elevated risk is due to seizures themselves, or from side effects antiepileptic drug (AED) treatment. In research presented at the 39th annual meeting of the Society for Neuroscience,...

2009-09-16 09:33:00

WASHINGTON, Sept. 16 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA's authority to require safety labeling changes, will highlight the risk of serious tissue injury when this drug is administered incorrectly. The agency is also alerting health care professionals to the new boxed warning for this product, which is used as a sedative...

2009-09-16 10:06:39

The U.S. Food and Drug Administration announced Wednesday it will require a boxed warning for the injectable form of the drug promethazine. FDA officials said the warning will highlight the risk of serious tissue injury when the drug is administered incorrectly. Promethazine is used as a sedative and to treat nausea and vomiting. Promethazine should neither be administered into an artery nor administered under the skin because of the risk of severe tissue injury, including gangrene, the FDA...

2009-09-08 09:30:00

SOMERSET, N.J., Sept. 8 /PRNewswire/ -- Meda Pharmaceuticals Inc. (Meda) today announced the commercial availability of EDLUAR(TM) (zolpidem tartrate sublingual tablets) in the United States. EDLUAR is indicated for the short-term treatment of insomnia characterized by difficulties with falling asleep. EDLUAR is the first available under-the-tongue formulation of zolpidem tartrate, which is the most prescribed treatment for insomnia. Zolpidem tartrate is also the active ingredient in...

2009-09-02 15:35:00

RICHMOND, Calif., Sept. 2 /PRNewswire-FirstCall/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) today announced that it will present at the BioCentury Thomson Reuters Newsmakers in the Biotechnology Industry Conference on Wednesday, September 16, 2009 at 11:00 am EDT. A live audio webcast and replay of the presentation will be available on the investor webpage at www.transcept.com. About Transcept Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the...

2009-08-28 18:47:00

BEVERLY HILLS, Calif., Aug. 28 /PRNewswire/ -- The Waismann Method, a pioneering medical opiate detoxification procedure, offers one of the most advanced medical procedures worldwide with the medical expertise and advanced technology to treat dependencies to Benzodiazepines, including Ativan, Xanax, Klonopin and Valium. The Waismann Method of Accelerated Benzodiazepine Neuro-Regulation (ABNR) involves a safe, medically-assisted withdrawal from Benzodiazepines in a hospital setting. This...