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news.Sanofi-Aventis has presented results from a Phase IIIb study that showed patients with chronic insomnia who were treated with 12.5mg of Ambien CR tablets experienced significant improvements in two key parameters of work performance, output and time management, compared with patients taking placebo.
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Patients with chronic insomnia can have a higher frequency of work-related problems including absenteeism, an increased rate of accidents, difficulty performing duties and less job satisfaction.
The study included 728 patients with chronic primary insomnia (478 treated with Ambien CR and 250 treated with placebo). Treatment with Ambien CR showed significantly higher improvement from baseline in work tasks at week 12 in work limitation questionnaire for both time management scale and the output scale compared to placebo, which was confirmed by an effect size analysis.
The majority of adverse events experienced by patients in the study were mild to moderate in intensity, and the most frequently reported adverse events by participants include headache, anxiety and somnolence.
Milton Erman, chief medical officer at Avastra USA, said: “These new data add to the growing body of evidence that shows that the treatment of chronic insomnia can improve next day functioning. This study demonstrates that Ambien CR is not only an effective treatment option to help patients with chronic insomnia fall and stay asleep, but is also associated with significant improvements in work performance.
“In that the performance improvements were correlated with the clinical improvements, this analysis demonstrated that Ambien CR-treated patients did better at work because their sleep improved,” Erman concluded.