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Eszopiclone (Lunesta) Can Be Used Up to 6 Months without Withdrawal Symptoms: Presented at ANA

By Paula Moyer

SAN DIEGO, CA -- September 29, 2005 -- The non-benzodiazepine sleep aid eszopiclone (Lunesta) can be used for up to 6 months without the development of withdrawal symptoms such as rebound insomnia when patients stop treatment, according to findings presented here September 27^th at the 130^th annual meeting of the American Neurological Association (ANA).

The findings support those of another study with a similar design and therefore confirm the safety of long-term use of eszopiclone, said presenting investigator Robert P. Rubens, MD, MBA, Senior Medical Director for Medical Affairs, Sepracor, Inc., Marlborough, Massachusetts, United States.

The data sets from the two studies "give clinical evidence of the sustained efficacy in terms of all of the sleep parameters and corresponding improvements in some of the next-day insomnia symptoms, such as ability to think clearly and concentrate, and alertness," Dr. Rubens said in an interview.

In this study, the investigators wanted to find out whether patients would develop rebound insomnia or withdrawal symptoms when they were switched to placebo in the setting of a blinded study.

The 830 subjects were 21 to 64 years old and met the criteria for primary insomnia outlined in the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) -- they slept no more than 6.5 hours per night or they had at least 30 minutes of sleep latency each night. The investigators randomized 280 patients to placebo and 550 patients to 3 mg of eszopiclone at bedtime. After being on this regimen for 6 months, the subjects on the study drug were switched to placebo for 2 weeks.

On a monthly basis throughout the study, subjects were asked to report on their sleep latency, total sleep time, and wake time after sleep onset, as well as several parameters of daytime functioning -- alertness, daytime sleepiness, ability to function and concentrate and physical well-being.

As had been reported previously,* eszopiclone was associated with significant improvement over baseline in all of the sleep parameters (P < .0001). Patients in the treatment group had an average decrease of 39.8 minutes of nightly sleep latency, an average of 19.6 fewer minutes of wake time after sleep onset, and an average increase of 80.9 minutes of total sleep time. Subjects in the treatment group also had significant improvements compared to placebo subjects on all daytime parameters (P < .05).

The findings were also reassuring regarding long-term use of the drug. During the placebo switch period, 0.6% of patients in the treatment group reported insomnia, compared to none in the group already on placebo.

"The most common adverse event in all of our studies was the unpleasant taste," Dr. Rubens said. "In this study it was reported by 20% of patients." In the other studies, 1.7% of patients withdrew due to this particular adverse event, compared to 0.5% of those on placebo. More often, patients find that the unpleasant taste, typically experienced on awakening, resolves when they eat breakfast and drink fruit juice."

Lunesta is manufactured by Sepracor, Inc., which funded the study.

* REFERENCES:
Rosenberg R, et al. Sleep Med. 2005 Jan;6(1):15-22
Krystal AD, et al. Sleep. 2003 Nov 1;26(7):793-9.


[Presentation title: Evaluation of the Efficacy and Safety of Eszopiclone over Six-Months of Treatment in Patients with Insomnia. Abstract 332]

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