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| |  Sonata Approved In Europe For Insomnia MADISON, NJ -- March 17, 1999 -- The European Commission has issued marketing authorisation to Wyeth-Ayerst Laboratories’ Sonata(R) (zaleplon) for the treatment of insomnia. Sonata, the first in a new class of non-benzodiazepine (pyrazolopyrimidine) chemical compounds, allows people to fall asleep quickly and awaken refreshed, without many of the side effects associated with other currently available sleep medications. Sonata has been studied in more than 3,700 patients throughout the United States, Canada and Europe, including elderly people ranging in age from 65 to 85. In clinical studies, Sonata has been shown to be effective in helping individuals fall asleep while preserving the natural sleep stages, including rapid-eye movement (REM), which should allow for a complete night's rest. Sonata is a novel hypnotic agent with a chemical structure unrelated to benzodiazepines (traditional sleep medications), barbituates, or other drugs with known hypnotic properties. Sonata has a short half-life (the time it takes for a drug to be eliminated from the body) of one hour, which minimises next-day residual effects. In addition, Sonata binds selectively to the brain's GABA(A) receptor complex (neurotransmitters that are associated with sleep), which may contribute to its overall qualities. In clinical trials, Sonata demonstrated an excellent safety profile and was well tolerated. The most common side effects with Sonata are headache, weakness, drowsiness and dizziness. Discontinuation of Sonata following clinical trials of up to 12 months did not result in dependence as evidenced by the lack of a withdrawal syndrome -- which is a problem associated with many currently available sleep medications. In addition, discontinuation of Sonata in clinical trials of four weeks at recommended doses did not cause rebound insomnia (insomnia that worsens when medication is stopped). Sonata will be available in 5-mg and 10-mg strengths in packages of seven and 14 capsules. The recommended daily dose for the short-term treatment of insomnia in adults is one 10-mg capsule and for elderly patients one 5-mg capsule.
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