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Title: Study Shows Zaleplon Helps People Get To Sleep Faster Without Residual Effects
URL: http://www.pslgroup.com/dg/8EB06.htm
Doctor's Guide
July 15, 1998


GLASGOW, SCOTLAND -- July 15, 1998 -- A new study shows that zaleplon, an investigational GABA-a benzodiazepine receptor agonist, helped people who experienced occasional (transient) insomnia fall asleep faster than placebo, without next-day residual effects.

This and other zaleplon studies were presented this week at the 21st Collegium Internationale Neuro-Psychopharmacologicum (CINP) congress.

"This new zaleplon data is encouraging for the large number of people who have difficulty sleeping from time to time because of everyday stress in their lives but are concerned that they'll feel drowsy the next morning after taking a sleep medication," said Thomas Roth, Ph.D., chief of Henry Ford Hospital Sleep Center, Detroit, one of the study investigators. "A medication like zaleplon that provides on-demand relief with little or no next-day effects has the potential to significantly help Americans get a healthy amount of sleep on a more regular basis."

The double-blind, placebo controlled study, included 244 people with occasional insomnia, aged 26 to 60. Previous sleep studies indicate that on the first night in a sleep lab, subjects experienced more difficulty sleeping than on subsequent nights. This study used this first night effect to produce a laboratory model of occasional (transient) insomnia.

Patients were randomly administered one of three treatments: zaleplon 10 mg, zaleplon 5 mg and placebo 30 minutes before going to bed. The study showed that zaleplon 10 mg helped people fall asleep 33 percent faster (18.7 minutes) than placebo (29.1 minutes). In addition, there was no difference between the zaleplon groups and placebo in the rate of next-day residual effects, including daytime sleepiness.

"This is exciting new information that has the potential to dramatically change the way Americans regard sleep medications," Dr. Roth said.

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