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| |  APA MEETING: Zaleplon Effective Against Insomnia Without Residual Effects WASHINGTON, DC -- May 17, 1999 -- Results from two new clinical trials show that Wyeth-Ayerst Laboratories’ zaleplon, an investigational treatment for insomnia, helps patients with difficulty sleeping get to sleep quickly without causing next-day residual effects such as grogginess, memory loss, difficulty concentrating, or lack of motor co-ordination. These findings were presented today at the annual meeting of the American Psychiatric Association (APA). "Often, many people who suffer from insomnia are caught in a quandary: they cannot sleep without medication, but they're concerned about next-day residual effects,” said Martin Scharf, Ph.D., of the Tri-State Sleep Disorders Center, Cincinnati, OH, lead study investigator. "These data are encouraging for many, because they suggest that zaleplon is effective without causing next-day residual effects." Zaleplon is a non-benzodiazepine, the first in a new chemical class of drugs (pyrazolopyrimidine). It is under review by the U.S. Food and Drug Administration for the treatment of insomnia in adults and elderly "Zaleplon is different than other sleep medications because it features a short, one-hour half-life -- which allows the drug to be eliminated from the body quickly," Dr. Scharf said. "This unique feature may be the reason that zaleplon does not cause next-day side effects and may be a good treatment option for people who suffer from insomnia." Nearly 84 million Americans are affected by insomnia each year, according to the National Sleep Foundation. Insomnia may be caused by many things, such as a change in sleeping or daily environments; 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. The National Commission on Sleep Disorders Research has estimated the total economic cost of insomnia -- including stress related, reduced workplace productivity - is approximately $150 billion US per year In the randomised, placebo-controlled trials, zaleplon was compared with flurazepam, another sleep medication. The first study examined 93 men and women between the ages of 18 and 45, who were treated with 10 milligrams (mg) of zaleplon, 30 mg of flurazepam, or placebo at bedtime. The second study examined 22 men and women between the ages of 18 and 60, who were treated with 10 mg of zaleplon, 30 mg of flurazepam, or placebo approximately 3.5 hours after bedtime. Patients were evaluated for sleepiness using the multiple sleep latency test (MSLT), the digit symbol substitution test (DSST), and the symbol-copying test (SCT). These tests measure the awareness of a patient the day after taking a sleep medication. Results from both studies show that all three test scores for those patients taking zaleplon did not differ significantly from those of the placebo group. By contrast, patients in both studies who received flurazepam showed significant impairment on the MSLT and DSST tests and patients in the second study also showed significant impairment on the SCT test. There were no serious long-term adverse events to zaleplon reported in the study. The most common side effects with zaleplon are headache, drowsiness and dizziness.
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