SAN DIEGO — Perimenopausal women who took eszopiclone for 1 month experienced significant improvements in sleep problems brought on by hot flashes, results from a randomized trial have found.
However, the drug had no apparent effect on the number or severity of daytime and nighttime hot flashes, Rob Mariani, Ph.D., reported during a poster session at the American Psychiatric Association's Institute on Psychiatric Services.
“I think this is another example of how you can improve the quality of your life in great part by improving how well you can sleep at night, especially in perimenopausal women who complain of sleep difficulties,” said Dr. Mariani, senior medical liaison for Sepracor Inc., which markets eszopiclone under the brand name Lunesta. The nonbenzodiazepine drug was approved by the Food and Drug Administration in 2004 for the treatment of insomnia.
Dr. Mariani went on to note that most of the published studies in the area of menopause and sleep “indicate that there are really not any significant sleep architecture changes in patients at menopause or perimenopausal age. Yet at the same time, women who are perimenopausal and postmenopausal complain about a significant number of sleep problems, especially those who have vasomotor symptoms.”
In a study funded by Sepracor Inc., Dr. Mariani and his associates enrolled 410 perimenopausal women aged 40–60 years who met the Stages of Reproductive Aging Workshop criteria for early menopausal transition, late menopausal transition, and early postmenopause, and who reported sleep latency of 30 minutes or more and total sleep time of 6 hours or less per night at least three times a week for 1 month.
Investigators randomized 201 women to receive 3 mg eszopiclone and 209 to receive placebo nightly for 4 weeks. Study end points included sleep latency, wake time after sleep onset, total sleep time, awakenings due to hot flashes, daytime hot flashes, and physician global evaluations.
Scales used included the Greene Climacteric scale, the Montgomery Asberg Depression Rating scale, and the Menopause Quality of Life scale.
Compared with the women in the placebo group, those who took eszopiclone had significant changes in median sleep latency (reduction from baseline of 18.6 minutes vs. 8.1 minutes) and in median wake time after sleep onset (reduction of 30.6 minutes vs. 16 minutes). The increase in median total sleep time was greater among women who took eszopiclone (48.9 minutes per day vs. 29.7 minutes).
Although eszopiclone did not affect the frequency or duration of daytime hot flashes, it did yield significant benefits in the physician global evaluation of menopause symptoms, the Montgomery Asberg Depression Rating scale score, the Greene Climacteric scale score, and in the vasomotor and physical domains of the Menopause Quality of Life scale.