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Eszopiclone Effective at Treating Menopause-Associated Insomnia: Presented at NAMS

By Paula Moyer

SAN DIEGO, CA -- October 5, 2005 -- Women with insomnia that originated in menopause or perimenopause appear to improvement significantly when they are treated with eszopiclone (Lunesta), investigators reported here September 30^th at the 16^th annual meeting of the North American Menopause Society (NAMS).

"The primary reason women in perimenopause or menopause have disturbed sleep is due to hot flashes, but not all women who have these symptoms are planning to use supplemental estrogen," said principal investigator Claudio N. Soares, MD, PhD, Associate Professor of Psychiatry, McMaster University, and Director, Women's Health Clinic, Hamilton, Ontario, Canada.

"We found that eszopiclone was associated with significant improvement in sleep and daytime function, and we saw no evidence of rebound insomnia," he said.

Dr. Soares and his co-investigators were interested in eszopiclone's potential because of the high prevalence of insomnia reported by women during this transitional phase. Therefore, they conducted a double-blind, placebo-controlled study to see whether 3 mg of eszopiclone would alleviate this problem.

The study consisted of a double-blind period, when women were either on treatment or placebo, as well as two follow-up periods that book-ended the double-blind period.

Before the double-blind phase there were 5 to 14 days of screening followed by 3 to 7 days when all subjects were on placebo in a single-blinded manner. The 4-week treatment phase followed, in which patients were randomized in double-blind fashion to treatment or placebo. After the double-blind phase, all patients were switched to placebo for 7 days and, again, followed in a single-blind fashion.

The investigators recruited 410 women who were 40 to 60 years old and who were confirmed to be perimenopausal or menopausal on the Greene Climacteric Scale. The women were at stages -2, -1, or +1a of the Stages of Reproductive Aging Workshop (STRAW) criteria. They had been screened for major psychiatric diagnoses.

Eligible women reported sleep latency of at least 30 minutes and total sleep time of no more than 6 hours per night.

The investigators randomized 201 women to receive 3 mg of eszopiclone per night and 209 to placebo for the double-blind period. Physicians examined the women 6 times throughout the study, including the pre- and post-treatment periods as well as the double-blind period.

The investigators gathered patient reports daily by a telephone voice response system regarding sleep latency, wake time after sleep onset, total sleep time, number of awakenings due to hot flashes, and number of daytime hot flashes.

Physician global evaluations (PGEs) and mood assessments with the Montgomery Asberg Depression Rating Scale (MADRS) after the treatment period. Adverse events were documented at each visit.

Results show a median reduction of 18.6 minutes of sleep latency in the women treated with eszopiclone compared to 8.1 minutes reduction in women in the placebo arm. Treated women reported a median of 30.6 minutes in wake time after sleep onset compared to a median of 16 minutes for women in the placebo arm (P < .007 for both).

The total sleep time increased a median of 48.9 minutes for women on eszopiclone, compared to a median of 29.7 minutes for those in the placebo (P < .0002).

The investigators observed no impact of treatment on frequency or duration of daytime hot flashes. However, there was a significant decrease in nocturnal awakenings due to hot flashes in the treatment group (P < .05). In addition, the women in the treatment arm showed significantly improvement in mood, as measured by MADRS score, and in PGEs (P < .03 and P < .0001, respectively).

The most common adverse effect was unpleasant taste among women treated with eszopiclone (17.7%), compared to the placebo group (0.5%). Other adverse events were similar in the two groups.

The study was funded by Sepracor Inc., which manufactures Lunesta.


[Presentation title: Evaluation of Eszopiclone 3 mg in the Treatment of Insomnia Associated with Menopause. Abstract P-76]

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