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Sonata(R) (zaleplon) C-IV Now Used by Astronauts in Space - Sleep Aid Available to Help Shuttle Astronauts in Outer Space Overcome the Difficulties of

 
PRESS RELEASE
Date Released: Wednesday, February 7, 2001
Source: Wyeth-Ayerst Laboratories

Noise from constantly whirring machines, uncomfortably close confines, a lack of gravity, and a sunrise and sunset every 90 minutes -- sleeping in space isn't easy. But now the space shuttle medicine cabinet offers astronauts the reliability and comfort of the sleep medication Sonata® (zaleplon) C-IV. Sonata, which made its maiden voyage on the 100th space shuttle mission, aboard the shuttle Discovery on October 11, is a prescription sleep medication which, in clinical trials, helped people fall asleep quickly and wake up naturally without residual effects, provided that patients remained inactive for four or more hours.

``Getting proper sleep can be very difficult when one is surrounded by distractions, whether in space or here on earth,'' says Philip de Vane, M.D., Vice President of Global Medical Affairs at Wyeth-Ayerst Laboratories. ``The favorable safety and efficacy profiles of Sonata make it a useful sleep medication for people who suffer from sleep difficulty.''

Restful sleep in space can be upset by numerous factors, including spine elongation (caused by lack of gravity) that results in back pain, high noise levels, and a sunrise or sunset every 90 minutes, which disrupt circadian rhythms that tell the body when to sleep. As a result, many astronauts use sleep aids.

Sonata can help people who have trouble falling asleep at bedtime, or later after trying to fall asleep on their own, with minimal evidence of next-day residual effects, such as difficulty concentrating or lack of motor coordination.

``We've already been able to help so many earth-bound insomnia sufferers -- travelers, shift workers, aging adults -- that it is exciting that Sonata should accompany America's space travelers as well,'' says Dr. de Vane.

About Sonata

In clinical trials, Sonata was shown to be effective in helping people fall asleep quickly, with minimal evidence of next-day residual effects such as grogginess, memory loss, difficulty concentrating, or lack of motor coordination.

``Zaleplon may revolutionize the way we treat insomnia because it can be taken on an as-needed basis,'' says Thomas Roth, Ph.D., Director of the Henry Ford Hospital Sleep Center in Detroit. ``Unlike other prescription sleep medications that need to be taken in anticipation of sleep problems, zaleplon can be taken either at bedtime or later, after people have tried to fall asleep on their own, as long as they have four or more hours remaining in bed.''

Sonata is indicated for the short-term treatment of insomnia in adults, including elderly patients. Although Sonata improved sleep time from baseline in clinical trials, it has not been shown to increase total time slept or decrease awakenings vs. placebo.

Hypnotics should generally be limited to seven to 10 days of use, and reevaluation of the patient is recommended if hypnotics are taken for more than two to three weeks. Prescriptions for Sonata should not exceed a one-month supply.

Until patients know how they will react to sleep agents, they should not engage in activities requiring mental alertness or motor coordination (e.g., driving or operating machinery) after taking Sonata or any other sleep agent.

Among the most common side effects of Sonata are headache, dizziness, and sleepiness.

About Wyeth-Ayerst Laboratories

Wyeth-Ayerst Laboratories, a division of American Home Products Corporation, is a major research-oriented pharmaceutical company with leading products in the areas of women's health care, cardiovascular therapies, central nervous system drugs, anti-inflammatory agents, infectious disease, hemophilia, oncology, vaccines, and generic pharmaceuticals.


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