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 reducing the likelihood of those next-day effects."
The Impact of Insomnia
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.
Clinical Studies of Sonata
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.
Clinical data have demonstrated that Sonata can be administered as needed, immediately before going to bed or after the patient has gone to bed and has experienced difficulty sleeping -- provided patients have four or more hours in bed before becoming active again. According to clinical studies, Sonata is not associated with memory loss, difficulty concentrating, or lack of motor coordination 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% vs 31% for placebo), drowsiness (5% vs 3% for placebo, and dizziness (7% vs 7% 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 coordination (e.g., driving or operating machinery).
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.
About Wyeth-Ayerst Laboratories
Wyeth-Ayerst Laboratories, a division of American Home Products Corporation
(NYSE: AHP), is a major research-oriented pharmaceutical company with leading
products in the areas of women's health care, cardiovascular disease therapies,
central nervous system drugs, anti-inflammatory agents, vaccines, and generic
pharmaceuticals. American Home Products is one of the world's largest
research-based pharmaceutical and health care products companies, and is a
leader in the discovery, development, manufacturing, and marketing of
prescription drugs, over-the-counter medications, vaccines, biotechnology,
agricultural products, and animal health care.
The statements in this press release that are not in historical facts are forward-looking statements that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of pharmaceutical research, product development and commercialization, the impact of competitive products, and patent, and other risks and uncertainties, including those detailed from time to time in AHP's periodic reports, including quarterly reports on Form 10-Q and the annual report on Form 10-K, filed with the Securities and Exchange Commission. Actual results may differ from the forward-looking statements.