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FIRST IN A NEW CLASS OF PRESCRIPTION SLEEP AIDS APPROVED FOR MARKETING

 SKOKIE, Ill., Dec. 21 /PRNewswire/ -- Ambien(TM) (zolpidem tartrate), the first of a new class of prescription sleep aids, has been approved for marketing by the U.S. Food and Drug Administration, G.D. Searle & Co. announced today.
 "Sleep disturbance is an extraordinarily prevalent problem in today's society, and the introduction of a new treatment option should be well received by the medical community. We expect Ambien to help fill a need that is not completely satisfied by existing medical therapies," said Joseph T. Curti, M.D., Searle's corporate executive vice president and president of North American Operations.
 Ambien has been shown in clinical studies and use overseas to be effective in helping individuals fall asleep quickly and increase their total sleep time. In addition, clinical research has shown that Ambien causes minimal next-day effects and is well-tolerated by the body.
 The medication is the first in a new class of chemical compounds called "imidazopyridines." Most medications currently prescribed to promote sleep are members of the older benzodiazepine class, the category to which drugs such as Halcion(R), Restoril(R) and ProSom(R) belong (see note).
 Ambien binds preferentially to a receptor in the brain that is believed to be related specifically to sleep promotion. This may explain why Ambien does not appear to suppress the deepest stage of sleep, which some experts believe is the most restorative part of a person's rest.
 "We haven't had a new class of sleep medications from which to choose in 30 years," commented Harry Lahmeyer, M.D., a professor of psychiatry at Northwestern Medical School in Chicago who served as a clinical investigator for Ambien. "Research findings indicate that Ambien tends to be more specifically sleep promoting than the benzodiazepines and does not have a lot of other effects."
 The safety and efficacy of Ambien were established after 3,000-plus individuals in the United States, Canada and Europe participated in more than 60 clinical studies. In addition, the product has been in use in Europe since 1988, where approximately 340 million patient nights of use have been monitored. In Europe, zolpidem is marketed by Synthelabo, the French pharmaceutical manufacturer that first discovered and developed the compound. The medication is sold there under the brand names Stilnox(R) or Stilnoct(R). Ambien was developed and tested for the North American market by Lorex, a joint venture between Synthelabo and Searle.
 When the recommended dose of Ambien was taken for up to ten nights in clinical studies, the only side effects that occurred at a rate above that caused by placebo were drowsiness, dizziness and diarrhea -- all reported by fewer than 2 percent of patients. With longer-term usage, the incidence of side effects increased: the most common side effect, dizziness, was reported by 5 percent of patients.
 Ambien, which will be available at some time in 1993, will enter a field of medicine that affects millions of Americans.
 "It is estimated that more than a third of all Americans suffer from insomnia at some time, and that almost one in ten have a chronic problem. Sleep deprivation, or poor-quality sleep, can affect one's life in a variety of ways," noted James Walsh, Ph.D., immediate past president of the American Sleep Disorders Association (ASDA). "Yet only a small percentage of these individuals seek help, and physicians often don't inquire about their patients' sleep habits. Consumer and physician education must be a priority."
 Searle is supporting organizations dedicated to educating physicians and consumers on insomnia. For example, Searle has provided a grant to the National Sleep Foundation, which will sponsor a series of insomnia workshops for primary-care physicians to be held in 20 cities in early 1993. In addition, it is supporting the ASDA in its efforts to disseminate the findings of the National Commission on Sleep Disorders Research, which was established by the U.S. Congress.
 "The clearance of Ambien is a milestone, because it is the fourth product approval we have achieved in 1992. During the previous five years, only three other pharmaceutical companies have earned three or more new chemical entities approved in a single year," said Dr. Curti.
 Searle is a research-based company that develops, manufactures and markets pharmaceutical products worldwide. Based in Skokie, it is a wholly owned subsidiary of Monsanto Company (NYSE: MTC).
 Based in Paris, Synthelabo is a research-based company that also develops, manufactures and markets pharmaceutical products worldwide.
 Lorex Pharmaceuticals, located in Skokie, is a joint venture of Searle and Synthelabo. Lorex develops and registers pharmaceutical products discovered by Synthelabo for marketing by Searle in North America.
 NOTE: Halcion is a registered trademark of the Upjohn Company. Restoril is a registered trademark of Sandoz Pharmaceuticals. ProSom is a registered trademark of Abbott Laboratories.
 -0- 12/21/92
 /CONTACT: Pam Rasmussen, 708-470-6163, or Jack Domeischel, 708-470-6720, both for Searle/
 (MTC)


CO: G.D. Searle & Co. ST: Illinois IN: MTC SU:

TS-GK -- NY003 -- 8649 12/21/92 09:23 EST
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Date:Dec 21, 1992
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