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Biotech / Medical : Neurocrine Biosciences (NBIX) -- Ignore unavailable to you. Want to Upgrade?

To: LLCF who wrote (169)	5/17/1999 7:51:00 PM
From: Miljenko Zuanic	Respond to of 1834

NBI-34060 older brother results: (note that this trials type are short and relative easy to conduct) SOURCE: Wyeth-Ayerst Laboratories Study Shows Zaleplon Helps Patients with Insomnia Get to Sleep, Without Causing Next-Day Residual Effects - Common Side Effects of Other Sleep Aids Include Memory Loss, Difficulty Concentrating - WASHINGTON, May 17 /PRNewswire/ -- Results from two new clinical trials show that 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 coordination. These findings were presented here 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, says 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 (FDA) for the treatment of insomnia in adults and elderly patients. Studies indicate that zaleplon can be taken before going to bed, or after a person has gone to bed and has experienced difficulty falling asleep, providing the medication is taken at least four hours before awakening. ''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,'' says Dr. Scharf. ''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 per year Clinical Trial Results In the randomized, 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. SOURCE: Wyeth-Ayerst Laboratories