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Ambien (Zolpidem Tartrate) CIV Sleep Aid Appears Safe, Effective With Longer-Term Use: Presented at APA

NEW YORK, NY -- May 7, 2004 -- Results of a 12-week, placebo-controlled clinical trial with AmbienŽ (zolpidem tartrate) CIV, the leading prescription sleep aid in the U.S.,1 demonstrated that the product safely and effectively treated insomnia intermittently with no evidence of tolerance or dose escalation -- complications often seen with extended use of older-generation sleep medications. The study, presented today at the 2004 American Psychiatric Association Annual Meeting, evaluated up to 5 nights of dosing per week, as needed, and underscored that the improvements in sleep provided by Ambien did not diminish over time and that symptoms did not worsen on the days the product was not used.

"There is emerging evidence that chronic insomnia has a significant effect on the safety, physical well-being, and emotional health of sufferers, and thus, it is increasingly clear that long-term management strategies are needed," said Michael Perlis, MD, lead study investigator and Associate Professor of Psychiatry and Neurosciences at the University of Rochester, New York. "The value of this study is that it provides data demonstrating that sleep medications such as Ambien retain their effectiveness, and may be beneficial with long-term, intermittent use."

According to the National Institutes of Health, more than 70 million Americans exhibit the symptoms of insomnia.3 Of these, the American Academy of Sleep Medicine estimates that nearly half, or 35 million people, suffer from chronic insomnia, defined as difficulty falling asleep or staying asleep every night or most nights for an extended time.

Investigators at nine U.S. sleep centers enrolled 199 patients who met the established criteria for primary insomnia. Primary insomnia is described as difficulty initiating or maintaining sleep, or experience of non-restorative sleep, for at least one month. The term "primary" indicates that the insomnia is not caused by any known physical or mental condition. Participants were randomized to either Ambien 10 mg or placebo for a period of 12 weeks. They were instructed to take one pill per night for at least 3 but no more than 5 nights per week and to return unused medication to the study site for verification purposes. Sleep diaries were provided and completed to assess the severity and frequency of sleep complaints and record medication use.

"We used non-nightly dosing because it reflects real-world use of sleep medications among chronic insomnia patients," said Dr. Perlis.

Patients were assessed for sleep latency (the amount of time needed to fall asleep), total sleep time, and other efficacy measurements. The clinical improvements seen in the Ambien group were stable from weeks 1 and 2 through weeks 11 and 12. In contrast, the benefits of placebo decreased over the study period.

There was no evidence that patients using Ambien escalated their medication intake when compared to the placebo group. The Ambien group limited its usage to 80 percent of available medication. The placebo group averaged one less pill per 2-week period. Both groups showed only a modest and comparable increase in doses per week.

"Clinical gains were clearly maintained with regular intermittent dosing of Ambien throughout the entire 12-week study period with a marked absence of dose escalation, habituation or tolerance," explained Dr. Perlis.

About Ambien
Ambien is indicated for the short-term treatment of insomnia.

There is a low occurrence of side effects associated with the short-term use of Ambien. The most commonly observed side effects in controlled clinical trials were drowsiness (2%), dizziness (1%), and diarrhea (1%). When you first start taking Ambien, use caution in the morning when engaging in activities requiring complete alertness until you know how you will react to this medication. As with any sleep medication, do not use alcohol while you are taking Ambien. Prescription sleep aids are often taken for 7 to 10 days as directed by your doctor. Your doctor will advise you about taking them longer. All people taking sleep medicines have some risk of becoming dependent on the medicine. In most instances, memory problems can be avoided if you take Ambien only when you are able to get a full night's sleep (7 to 8 hours) before you need to be active again.


SOURCE: Sanofi-Synthelabo

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