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| |  FDA Approves Sonata For Treatment Of Insomnia MADISON, NJ -- Aug. 16, 1999 -- The United States Food and Drug Administration has approved Wyeth-Ayerst Laboratories’ Sonata(R) (zaleplon) for the short-term (generally seven to 10 days) treatment of insomnia in adults, including elderly patients. "Sonata may revolutionise the way we treat insomnia because it can be taken on an as-needed basis," said Thomas Roth, Ph.D., director of the Henry Ford Hospital Sleep Center, Detroit, MI. "Unlike other prescription sleep medications that need to be taken in anticipation of sleep problems, Sonata can be taken either at bedtime or sometime later, after they have tried to fall asleep on their own, as long as they have four or more hours remaining in bed." Sonata is the first in a new chemical class of nonbenzodiazepine (pyrazolopyrimidine) compounds and has a unique mechanism of action and pharmacokinetic profile, which allows for flexible administration (such as at bedtime or after difficulty falling asleep, provided there are four or more hours remaining before becoming active again). Sonata is not a sleep maintenance drug. Rather, it remains at its binding site for only a short time and is rapidly eliminated after sleep is initiated so the patient's natural sleep processes can take over. In clinical trials, Sonata did not show evidence of next-day grogginess or hangover effects commonly associated with other sleep medications. "Although millions of Americans have difficulty falling asleep, many people do not take sleep aids for fear of next-day grogginess," Dr. Roth said. "Now, we have a medication that can be taken on an as-needed basis to help people get the sleep they need, while reducing the likelihood of those next-day effects." Insomnia affects nearly 84 million Americans, according to the National Sleep Foundation (NSF). Insomnia may be caused by a number of factors, including a change in sleeping or daily environments, such as a new home or job; jet lag; a new work schedule; pain from arthritis, headache, menstrual cramps, or backache; stress or anxiety; or use of certain medications. Sonata has been studied in more than 2,800 patients throughout the United States, Canada and Europe, including elderly people ranging in age from 65 to 85. In clinical studies, Sonata has been shown to be effective in helping individuals fall asleep fast (within 30 minutes), allowing the natural sleep process to take over. According to clinical studies, Sonata is not associated with memory loss, difficulty concentrating, or lack of motor co-ordination four hours after dosing. In addition, Sonata has a short half-life (the time it takes for a drug to be eliminated from the body) of approximately one hour, compared with longer half-lives of other sleep medications. In clinical studies, among the most common side effects with Sonata are headache (28 percent versus 31 percent for placebo), drowsiness (five percent versus three percent for placebo) and dizziness (seven percent versus seven percent for placebo), none of which were significantly different from patients receiving placebo. Studies of Sonata have shown no evidence of memory or psychomotor impairment four or more hours after administration of Sonata. Until patients know how they will react to Sonata or any sleep agent, they should not engage in activities requiring mental alertness or motor co-ordination. Sonata will be available in 5-mg and 10-mg capsules. The recommended dose for most nonelderly adults (less than age 65) is one 10-mg capsule; elderly patients are advised to take one 5-mg capsule.
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