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Study confirms safety and tolerability of zaleplon for long-term treatment of insomnia

- Even after 12 months of treatment, zaleplon remained effective, did not cause withdrawal symptoms upon discontinuation -

LONDON, September 21, 1999 -- Results from a new clinical trial confirm that zaleplon is an effective, safe, and well tolerated medication for the long-term treatment (up to 12 months) of insomnia. Previous studies have proven the safety and tolerability of zaleplon for short-term use (up to four weeks) in the treatment of insomnia. The new study was presented here today at the annual meeting of the European College of Neuropsychopharmacology (ECNP).

Zaleplon received marketing authorization from the European Commission in May 1999 for the short-term treatment of insomnia in patients who have difficulty falling asleep.

"Because sleep medications may be addictive, it generally is advised not to use them for more than four weeks at a time," says Martin Scharf, Ph.D., Director of the Tri-State Sleep Disorders Center, and lead study investigator of one of the studies. "However, these data confirm that zaleplon is different from other sleep medications because it can be used safely for up to one year, without causing any withdrawal symptoms upon discontinuation."

Approximately one-third of the general population suffers from insomnia. Short-term or transient 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. Chronic insomnia, or insomnia that lasts for more than one month, may be related to medical or behavioral problems.

"Treating chronic insomnia is very tricky, because the condition usually requires a longer treatment period than four weeks -- the maximum time for which most sleep medications can be used," says Dr. Scharf. "These data are encouraging, because they demonstrat
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Contact: Andrew Edwards
aedwards@edelman.com
212-704-8193
Edelman Public Relations
21-Sep-1999


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