First new product for insomnia in over five years offers flexible administration
MADISON, NJ, AUGUST 16, 1999 -- American Home Products Corporation's (NYSE:AHP) pharmaceutical division, Wyeth-Ayerst Laboratories, announced today that SonataR (zaleplon) has been approved by the U.S. Food and Drug Administration (FDA) for the short-term (generally 7-10 days) treatment of insomnia in adults, including elderly patients. Sonata will be available once the U.S. Drug Enforcement Administration (DEA) scheduling process is complete.
"Sonata 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, 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 (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.
"Although millions of Americans have difficulty falling asleep, many
people do not take sleep aids for fear of next-day grogginess," says Dr. Roth.
"Now, we have a medication that can be taken on an as-needed basis to help
people get the sleep they need, while
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Contact: Audrey Ashby, Wyeth-Ayerst Laboratories
610-971-5823
Edelman Public Relations
16-Aug-1999