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| |  Sonata Launched In Denmark And Sweden For Insomnia MADISON, NJ -- May 19, 1999 -- American Home Products Corp.’s Sonata(R) (zaleplon), a new treatment for insomnia, is now available in Denmark and Sweden. Sonata, a unique non-benzodiazepine (pyrazolopyrimidine) chemical compound, is indicated for the treatment of insomnia in patients who have difficulty falling asleep. Sonata allows people to fall asleep quickly and awaken refreshed. Sonata's short half-life allows for a restful night's sleep, while minimising the residual effects associated with other currently available sleep medications, such as memory loss, difficulty concentrating, or lack of motor co-ordination. Due to Sonata's short plasma half-life, alternative therapy should be considered if early awakening is experienced. Sonata has been studied in more than 3,700 patients throughout Europe, the United States and Canada, 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). Sonata has a novel chemical structure unrelated to benzodiazepines (traditional sleep medications), barbiturates, or other drugs with known hypnotic properties. Sonata has a short half-life of one hour, which should allow for minimal next-day residual effects while allowing for a restful night's sleep. In addition, Sonata binds selectively to the brain's GABAA receptor complex (neurotransmitters that are associated with sleep), which may contribute to its overall qualities of rapid action and minimal residual effects. 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. There are no drugs specifically contraindicated with Sonata. 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). In both countries, 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 (up to two weeks) of insomnia in adults is one 10 mg capsule, and for elderly patients one 5 mg capsule. Sleep deprivation can cause a variety of problems, including moodiness, loss of memory, inability to concentrate, and loss of energy. Insomnia also can be associated with more serious medical conditions, such as depression and anxiety, and is an important factor in automobile and industrial accidents.
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