Improving Sleep Duration in Postmenopausal Women

Postmenopausal woman may have a reliable nonhormonal treatment option available to help reduce vasomotor symptoms, according to the results of a pooled analysis of two phase III studies recently published in Menopause.

In the analysis, the use of paroxetine 7.5 mg among postmenopausal woman significantly improved the number of nighttime awakenings caused by vasomotor symptoms and increased sleep duration.

“Improvements in nighttime awakenings and sleep duration occur without increased sedation, reduced sleep onset latency, or increased sleep-related adverse events, suggesting that, in these studies, paroxetine 7.5 mg has a selective therapeutic effect on sleep parameters related to vasomotor symptoms,” wrote researcher JoAnn V. Pinkerton, MD, of the University of Virginia, Charlottesville, and colleagues.

Pinkerton and colleagues collected data from two phase 3 studies of paroxentine. In the studies, postmenopausal woman were randomly assigned to paroxentine 7.5 mg (n=591) or placebo (n=593). Both studies looked at the drug’s efficacy and safety for 12 weeks; one of the two studies extended this analysis to 24 weeks.

All enrolled patients completed regular assessments of nighttime awakenings attributed to vasomotor symptoms, sleep-onset latency, sleep duration, and sleep-related adverse events.

Comparing the two treatment groups, women assigned paroxentine had a 39% reduction in nighttime awakenings due to vasomotor symptoms by week 4 compared with a 28% reduction reported among women assigned placebo (P=.0049). At week 12, women assigned to the study drug had a 54% reduction in awakenings compared with a 43% reduction in the placebo arm (P=.0001). This benefit was sustained among women assigned to paroxetine when looking at data from the study that extended observation to 24 weeks.

Paroxetine was also associated with an increase in sleep duration in the two studies. By week 4, women assigned to the drug reported an 8% improvement in sleep duration, about 31 minutes, compared with a 4% improvement, or 16 minutes, in the placebo arm (P=.0075). This improvement was sustained through weeks 12 and 24.

“The improvement in sleep duration with paroxetine 7.5 mg (an increase of up to 37 min/night from baseline) compares favorably with results obtained with agents used specifically for the treatment of insomnia, such as zolpidem, which has been shown to increase total sleep time by 51 minutes or more per night,” the researchers wrote.

A similar proportion of patients in each arm reported sleep-related treatment-emergent adverse events, with 3.1% of patients in each arm reporting at least one.