Ramelteon for the treatment of insomnia in menopausal women.
OBJECTIVE
Sleep disturbances have been reported to be one of the most troubling manifestations of menopause. While hormone replacement therapy (HRT) has historically been considered a first-line treatment for menopausal insomnia, many women are now seeking alternative treatments due to concerns about the risks and side-effects of HRT. The goal of this study was to evaluate the effect of ramelteon, a selective melatonin receptor agonist, for the treatment of menopausal insomnia.


METHODS
A total of 20 healthy peri- and postmenopausal women with insomnia participated in this six-week, prospective, open-label trial of ramelteon (8 mg) at an academic medical centre. Participants completed sleep-wake diaries on a daily basis for six weeks. Self-report measures of sleep impairment, daytime functioning, quality of life and mood were also completed on a bi-weekly basis.


RESULTS
Significant improvements in latency to sleep onset, total sleep time and sleep efficiency were observed in diary data while gains in sleep quality, sleep impairment, daytime functioning, quality of life and mood were found in self-report measures. There was no evidence of tolerance or rebound over the course of the trial.


CONCLUSIONS
Overall, results suggest that ramelteon is an effective non-hormonal approach for the treatment of insomnia in menopause. Randomized-controlled trials are needed to further evaluate the efficacy of this intervention.
Dobkin
Roseanne DeFronzo
RD
Department of Psychiatry, UMDNJ-Robert Wood Johnson Medical School, 675 Hoes Lane, Piscataway, NJ 08854, USA. dobkinro@umdnj.edu
Menza
Matthew
M
Bienfait
Karina L
KL
Allen
Lesley A
LA
Marin
Humberto
H
Gara
Michael A
MA
D000328:Adult; D005260:Female; D006801:Humans; D007192:Indenes / Q000627:therapeutic use*; D008875:Middle Aged; D017698:Postmenopause; D044094:Receptors, Melatonin / Q000819:agonists*; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*
D007192:Indenes; D044094:Receptors, Melatonin; C495910:ramelteon