Recent Trials Provide Further Arguments in Favor of the Use of Zolpidem in an "as Needed" Treatment Schedule
The first trial, the results of which were presented at the Congress by the principal investigator Pr. James Walsh (Sleep Medicine and Research Center, Saint Luke's Hospital and the Department of Psychiatry, St. Louis University Health Sciences Center, Saint Louis, Missouri, U.S.) compared the efficacy of zolpidem 10mg vs. placebo when each were taken "as needed", provided that a pill was taken 3 to 5 times per week, on nights selected by the patients themselves. Subjective sleep data were collected for ten consecutive weeks using daily morning sleep questionnaires. Global patient and investigator evaluations were completed after two weeks of randomized treatment.
The study results revealed significant differences between the two groups in favor of zolpidem at all points measured (p< 0.01). When all randomized nights were included, reported total sleep time was significantly greater for zolpidem than placebo during weeks 1-2 and 3-4 (both p< 0.02), and there was a trend (p< 0.09) for greater total sleep time for zolpidem during weeks 5-6.
Sleep questionnaires and global patient and investigator evaluations indicate significant benefit from the "as needed" use of zolpidem 10mg., as compared to placebo, over the eight weeks of treatment. There was no evidence of rebound insomnia. The number of nights per week on which a pill was taken did not increase, indicating that there was no "drug-seeking" behavior evidenced during the trial.
The second trial, results of which were presented at the Congress by the chief investigator Dr. Göran Hajak (Department of Psychiatry and Psychotherapy, Georg-August University Göttingen, Germany) included 2,690 patients with chronic sleep disorders (over 4 weeks) and was conducted with the collaboration of primary care physicians. Patients were told to use zolpidem "as needed" with a maximum of five tablets per week. Pharmacotherapy was amended by the optional use of behavioral, stimulus control therapy in a multicenter study conducted in over 500 centers in a primary care setting.
After the three week treatment period, the average number of zolpidem tablets used decreased by 28% from 3.6 to 2.6 tablets (p< 0.01). Furthermore, the efficacy of the zolpidem "as needed " treatment schedule was rated as "very good" or "good" in 92% of cases by the investigators, whilst its safety was rated "very good" or "good" in 97.4% of cases.
"Since the study was conducted in a primary care setting, it very closely reflected what physicians actually could do when dealing with insomnia patients", said Dr. Hajak. "The data underline the validity and feasibility of zolpidem in an "as-needed" treatment schedule in a real-life situation. The results also indicate zolpidem can be safely and effectively prescribed "as needed" to offer relief to insomnia patients from their symptoms."
The results of these two trials further reinforce the findings obtained from four double-blind clinical trials conducted with zolpidem on more than 1,200 insomniac patients in the U.S. and Europe, presented at the World Federation of Sleep Research Societies (WFSRS) Congress held in Dresden, Germany in October 1999.
"The overall program conducted on the zolpidem "as needed" treatment schedule confirms that, under medical supervision, the non-continuous use of zolpidem is feasible, safe and effective and offers an interesting therapeutic solution for the management of insomnia patients", concluded Dr. Hajak.
Zolpidem, marketed under the tradenames STILNOX® and AMBIEN® (in the U.S.), was first launched in 1988 and is currently the world's leading hypnotic agent.
Through the very extensive research programme already conducted on zolpidem, Sanofi-Synthelabo continues to further its commitment to optimize the management of patients suffering from insomnia.
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Posted: June 2004