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| |  Sonata (Zaleplon) Clears Final Regulatory Hurdle For U.S. Insomnia Market MADISON, N.J. -- September 15, 1999 -- American Home Products Corporation’s pharmaceutical division, Wyeth-Ayerst Laboratories, announced today that Sonata® (zaleplon) has cleared the final hurdle for U.S. marketing and is being shipped today to distribution centers across the U.S. This action is possible because the company has received U.S. Drug Enforcement Administration (DEA) scheduling and is now classified - like all other prescription sleep medications - as a Schedule IV controlled substance. Sonata should be available to patients nationwide by early next week. According to the DEA, a Schedule IV controlled substance is defined as having a real but low potential for abuse - and if abused, a limited physical or psychological dependence effect - compared with the substances in other classifications (Schedules I-III). The U.S. Food and Drug Administration (FDA) approved Sonata on August 16, 1999 for the short-term (generally 7-10 days) treatment of insomnia in adults, including elderly patients. Insomnia affects nearly 84 million Americans, according to the National Sleep Foundation (NSF). The condition 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 is the first in a new chemical class of nonbenzodiazepine (pyrazolopyrimidine) compounds. It has a unique mechanism of action and pharmacokinetic profile, which allows for flexible administration (i.e., 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. However, until patients know how they will react to Sonata or any sleep agent, they should not engage in activities requiring mental alertness or motor coordination (e.g. driving or operating machinery). "Sonata may profoundly impact the way we treat insomnia because it can be taken on an as needed basis," says Dr. Thomas Roth, 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 will be available soon in 5-mg and 10-mg capsules. The recommended dose for most adults younger than age 65 is one 10-mg capsule; elderly patients are advised to take one 5-mg capsule.
Related Links: Wyeth-Ayerst.
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