article · Menopause The Journal of The North American Menopause Society
A study investigated the effect of low-dose paroxetine (7.5 mg) on sleep disturbances in postmenopausal women experiencing moderate to severe vasomotor symptoms. Two phase 3 randomised controlled trials compared paroxetine 7.5 mg with placebo over 12 or 24 weeks. The findings showed that paroxetine significantly reduced nighttime awakenings attributed to vasomotor symptoms within four weeks, with sustained effects. It also significantly increased nighttime sleep duration. However, there were no significant differences observed in sleep-onset latency or sleep-related adverse events like sedation between the paroxetine and placebo groups.
This research is important because it identifies an effective nonhormonal treatment for improving sleep quality in women experiencing menopausal vasomotor symptoms. Better sleep can significantly enhance the overall well-being and daily functioning of women during menopause.
This research demonstrates that paroxetine 7.5 mg can improve sleep for postmenopausal women with moderate to severe vasomotor symptoms. As paroxetine 7.5 mg is already an approved nonhormonal treatment for these symptoms, this finding supports its use by healthcare providers to address associated sleep disturbances, offering a near-market solution for patients.
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OBJECTIVE: Sleep disturbances are common among women in midlife; prevalence increases among perimenopausal/postmenopausal women with vasomotor symptoms. Paroxetine 7.5 mg is the only nonhormonal treatment that has been approved in the United States for moderate to severe vasomotor symptoms associated with menopause. In two pivotal phase 3 studies evaluating its efficacy and safety, improvements in sleep disturbances were also prospectively evaluated. METHODS: Postmenopausal women with moderate to severe vasomotor symptoms were randomly assigned to paroxetine 7.5 mg (n = 591) or placebo (n = 593) once daily for 12 weeks (both studies) or 24 weeks (24-wk study). Predefined assessments on weeks 4, 12, and 24 included number of nighttime awakenings attributed to vasomotor symptoms, sleep-onset latency, sleep duration, and sleep-related adverse events. The two studies' data for weeks 1 to 12 were pooled. RESULTS: At baseline, participants reported a mean of 3.6 awakenings/night attributed to vasomotor symptoms. Nighttime awakenings attributed to vasomotor symptoms were significantly reduced within 4 weeks of initiating paroxetine 7.5 mg treatment (39% reduction vs 28% for placebo; P = 0.0049), and reductions were sustained through 12 or 24 weeks of treatment. Paroxetine 7.5 mg treatment also significantly increased nighttime sleep duration (week 4, +31 vs +16 min for placebo; P = 0.0075), but no significant between-group differences in sleep-onset latency or sleep-related adverse events such as sedation were observed. CONCLUSIONS: In postmenopausal women treated for menopausal vasomotor symptoms, paroxetine 7.5 mg significantly reduces the number of nighttime awakenings attributed to vasomotor symptoms and increases sleep duration without differentially affecting sleep-onset latency or sedation.
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DOI: 10.1097/gme.0000000000000311
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