Trial reportMenopause (New York, N.Y.)2015
Low-dose paroxetine (7.5 mg) improves sleep in women with vasomotor symptoms associated with menopause.
Trial report in Menopause (New York, N.Y.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 47 citations in OpenAlex.
- The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors and Serotonin-Norepinephrine Reuptake Inhibitors in the Treatment of Menopausal Hot Flashes: A Systematic Review of Clinical Trials.Iranian journal of medical sciences · 2022Pooled it
- Efficacy of Low-Dose Paroxetine for the Treatment of Hot Flushes in Surgical and Physiological Postmenopausal Women: Systematic Review and Meta-Analysis of Randomized Trials.Medicina (Kaunas, Lithuania) · 2019Pooled it
- Midlife Sleep and Circadian Health: Implications for Cardiovascular and Cognitive Outcomes.Obstetrics and gynecology clinics of North America · 2026Review
- Review
- Management of menopausal hot flushes. Recommendations from the Spanish Menopause Society.European journal of obstetrics & gynecology and reproductive biology: X · 2025Review
- Sleep Disturbance and Perimenopause: A Narrative Review.Journal of clinical medicine · 2025Review
- The Current Strategy in Hormonal and Non-Hormonal Therapies in Menopause-A Comprehensive Review.Life (Basel, Switzerland) · 2023Review
- A Clinical Review on Paroxetine and Emerging Therapies for the Treatment of Vasomotor Symptoms.International journal of women's health · 2022Review
- Contemporary Non-hormonal Therapies for the Management of Vasomotor Symptoms Associated with Menopause: A Literature Review.TouchREVIEWS in endocrinology · 2021Review
- Qualitative study: burden of menopause-associated vasomotor symptoms (VMS) and validation of PROMIS Sleep Disturbance and Sleep-Related Impairment measures for assessment of VMS impact on sleep.Journal of patient-reported outcomes · 2021Article
- The Use of Antidepressant Drugs in Climacteric Syndrome.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2020Article
- Sleep and Sleep Disorders in the Menopausal Transition.Sleep medicine clinics · 2018Review
- Sleep problems during the menopausal transition: prevalence, impact, and management challenges.Nature and science of sleep · 2018Review
- Comparison of the effects of stellate ganglion block and paroxetine on hot flashes and sleep disturbance in breast cancer survivors.Cancer management and research · 2018Article
- Insomnia in women approaching menopause: Beyond perception.Psychoneuroendocrinology · 2015Article
- Critical appraisal of paroxetine for the treatment of vasomotor symptoms.International journal of women's health · 2015Review
- Comparative Efficacy and Safety of Clonazepam versus Nortrptilline on Menopausal Symptom among Forty Plus Women: A Prospective, Open-Label Randomized Study.Journal of mid-life healthArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveSleep 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.
methodsPostmenopausal 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.
resultsAt 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.
conclusionsIn 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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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.