Eszopiclone in patients with insomnia during perimenopause and early postmenopause: a randomized controlled trial.
OBJECTIVE
To evaluate eszopiclone 3 mg for treatment of insomnia in perimenopausal and early postmenopausal women, as well as the impact of insomnia treatment on mood, menopause-related symptoms, and quality of life.


METHODS
This was a double-blind, placebo-controlled study with 410 women (aged 40-60; perimenopausal or early postmenopausal) who reported insomnia defined as sleep latency of at least 45 minutes and total sleep time less than or equal to 6 hours per night for at least 3 nights per week over the previous month. Patients were randomly assigned to eszopiclone 3 mg or placebo nightly for 4 weeks. Sleep data were collected once a day. Physician global assessments of menopause, menopause-specific questionnaire, Greene Climacteric Scale, the Montgomery Asberg Depression Rating Scale, and the Sheehan Disability Scale were collected at baseline and end of treatment.


RESULTS
Patients receiving eszopiclone reported improvements in sleep induction, sleep maintenance, sleep duration, sleep quality, and next-day functioning relative to placebo (P<.05). Patients receiving eszopiclone reported fewer total awakenings and awakenings due to hot flushes (P<.05). Eszopiclone use led to greater improvement in Montgomery Asberg Depression Rating Scale scores (P<.05) and physician global assessments of menopause scores (P<.001); total Greene Climacteric Scale score and the vasomotor and psychological sub-scores (P<.05); vasomotor and physical domains of the menopause-specific questionnaire (P<.05); and family life/home domain of the Sheehan Disability Scale (P<.05).


CONCLUSIONS
In this study, eszopiclone provided significant improvements in sleep and positively impacted mood, quality of life, and menopause-related symptoms in perimenopausal and early postmenopausal women with insomnia.


BACKGROUND
ClinicalTrials.gov www.clinicaltrials.gov NCT00366093


METHODS
I.
Soares
Claudio N
CN
Department of Psychiatry and Behavioral Neurosciences, McMaster University, Hamilton, Ontario, Canada, and Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA. csoares@mcmaster.ca
Joffe
Hadine
H
Rubens
Robert
R
Caron
Judy
J
Roth
Thomas
T
Cohen
Lee
L
D000339:Affect / Q000187:drug effects; D053961:Azabicyclo Compounds; D004311:Double-Blind Method; D005260:Female; D019584:Hot Flashes / Q000503:physiopathology; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D047648:Perimenopause; D010879:Piperazines / Q000008:administration & dosage / Q000627:therapeutic use*; D017698:Postmenopause; D011788:Quality of Life; D012890:Sleep / Q000187:drug effects; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*
D053961:Azabicyclo Compounds; D006993:Hypnotics and Sedatives; D010879:Piperazines; C515050:zopiclone