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| |  Sonata Launched In Germany For Insomnia MADISON, NJ -- June 2, 1999 -- American Home Products Corp.’s Wyeth Lederle Division has launched Sonata(R) (zaleplon), a new treatment for insomnia, in Germany. Germany is the third European country where Sonata is now available. Sonata received marketing authorisation from the European Commission on March 12, 1999 and has been launched in Denmark and Sweden. The product is also currently under regulatory review by the United States Food and Drug Administration. 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 (within 30 minutes) and awaken refreshed. Sonata can be taken immediately before going to bed, or after bedtime when experiencing difficulty falling asleep. Sonata's flexible dosing will allow 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. Patients who experience nocturnal awakenings may require alternative therapy. Insomnia affects approximately one-fourth of the general population in Germany. Insomnia may be caused by a number of factors, including a change in sleeping or daily environments, such as 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. 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. Sonata has been studied in more than 3,700 patients throughout Europe, the U.S. 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), barbituates, or other drugs with known hypnotic properties. Sonata has a short half-life of one hour, which should minimise 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. Sonata was well tolerated in clinical trials. 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 Germany, 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.
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