Background: Sleep disturbances are common during the menopausal transition. They can exacerbate many other symptoms, such as depression and anxiety, and can worsen quality of life. Eszopiclone (Lunesta) has been shown to facilitate sleep onset during menopause. Joffe and colleagues studied the effect of eszopiclone on other sleep parameters and related menopausal symptoms.
The Study: The authors conducted an 11-week randomized, double-blind, placebo-controlled, crossover study of perimenopausal and postmenopausal women who reported at least one month of difficulty initiating and maintaining sleep, in addition to other menopausal symptoms. Symptoms were confirmed by sleep and symptom diaries that were kept for seven days. Baseline assessments included a psychiatric interview and completion of rating scales for anxiety, depression, and psychiatric conditions. Women with clinically significant psychiatric disorders, sleep apnea, or other sleep conditions (including use of hypnotic medications) were not eligible for the study. Participants were allowed to continue use of hormone or antidepressant therapy if the dosage had been stable for at least eight weeks before the study began.
A total of 59 participants were randomly allocated to initial treatment with 3 mg of eszopiclone or an identical placebo. After four weeks of therapy, followed by a two-week washout period, treatments were reversed for the final four weeks of the study.
Symptoms were monitored using a sleep diary and the Insomnia Severity Index, a seven-item self-reported questionnaire. Other symptoms were monitored with symptom diaries, the Menopause Quality of Life Scale, the Beck Anxiety Inventory, the Montgomery-Åsberg Depression Rating Scale, and the Sheehan Disability Scale.
Results: Overall, 46 women completed the study. Non-completion was principally attributed to adverse effects or loss to follow-up. Participants were approximately 52 years of age, were predominantly white (71 percent), and had a mean body mass index of 27.5 kg per m2. Hormone use was reported by 8.5 percent and antidepressant use by 15.3 percent. The groups were comparable in demographic and symptom measures when entering the study. All participants initially reported hot flashes, with initial averages of 2.4 episodes during the day and 2.1 at night. Sleep disorders and depressive symptoms were common and equally represented in the two treatment groups.
Treatment with eszopiclone was associated with significant reductions in Insomnia Severity Index scores compared with placebo. After four weeks of eszopiclone treatment, 87 percent of participants achieved scores of 7 or less, compared with 34 percent of those in the placebo group. Eszopiclone treatment was associated with improvements in all measures of sleep duration and efficiency. Use of eszopiclone was also associated with a reduction in nocturnal hot flashes, but not diurnal episodes. Improvements were noted in measures of depression, quality of life, and anxiety. Functional disability scores showed improvement during eszopiclone treatment, but this trend did not achieve statistical significance.
Conclusion: The authors conclude that eszopiclone treatment improves sleep disturbances in perimeno-pausal and postmenopausal women and is associated with significant improvements in depressive symptoms and quality-of-life measures.