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| |  Studies Show Greater Efficacy Of Zaleplon Over Current Sleep Medications NEW ORLEANS, LA -- June 22, 1998 -- Phase III trial results show that zaleplon, an investigational GABAA benzodiazepine receptor agonist, helps people with difficulty sleeping get to sleep faster than those who take the current market leader, Ambien® (zolpidem). The trial results and two other studies were presented this week at the 12th annual meeting of the Association of Professional Sleep Societies in New Orleans. The Phase III head-to-head study involved 598 people with sleep disorders who were observed at 27 sleep centres throughout the United States. Following seven-days of pre-study treatment with placebo, patients received zaleplon 5, 10 or 20 mg, zolpidem 10 mg, or placebo for 28 days. Results showed a dose-dependent improvement in time to fall asleep and an increase in the average times slept with higher doses of zaleplon, as compared to placebo. Discontinuation of zaleplon did not result in withdrawal symptoms. In contrast, during the first two withdrawal nights, patients who had taken zolpidem took longer to fall asleep and slept less than those taking placebo. "Zaleplon improves overall sleep quality and the amount of sleep a person gets without the side effects commonly associated with many of today's sleep aids," reports Martin Scharf, Ph.D., of the Tri-State Sleep Disorders Center, Cincinnati, OH, a zaleplon study investigator. "The elimination half-life of zaleplon, which is the amount of time it takes the body to metabolise the drug, is just over one hour -- significantly shorter than that of zolpidem, which is 2.6 hours. This may contribute to the absence of sleep hangovers in the zaleplon group that was observed in the study." "This new comparative data about the efficacy of zaleplon versus zolpidem is exciting for those who are looking for a rapid sleep onset without next day withdrawal effects. Our clinical studies indicate that patients would have the option of taking zaleplon as needed during the night without having to worry about next-day residual side effects." In two other placebo-controlled studies presented this week, the night-time administration of zaleplon 10 and 20 mg was compared to DalmaneO (flurazepam) 30 mg and placebo to detect next-day residual effects, including sleepiness. Neither dose of zaleplon caused significantly more next-day drowsiness compared to placebo. However, flurazepam 30 mg group caused pronounced next-day sleepiness compared to placebo. "This study shows that patients can take zaleplon up to five hours before waking and still be free of hangover symptoms commonly associated with sleep medications, such as daytime sleepiness, " Dr. Scharf said. "The data suggests the potential for a unique flexibility in the use of zaleplon. People can take zaleplon whether they have trouble falling asleep, or if they wake up in the middle of the night."
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