Postmenopausal Women with Vasomotor Symptoms Have Frequent Sleep Issues

Hadine Joffe, MD, MSc

Credit: LinkedIn

Sleep disturbance and dissatisfaction with sleep quality are highly prevalent among postmenopausal women with vasomotor symptoms, according to analysis from the OASIS trials.

In new data presented during the late-breaking session at the SLEEP 2024 Annual Meeting in Houston, TX, this week, a multinational team of investigators reported from qualitative analyses that postmenopausal women with vasomotor symptoms were “often” or “always” having difficulties with sleep at baseline of a clinical trial. The research would suggest the need for more support from clinicians to address worsening sleep among postmenopausal women.

Investigators led by Hadine Joffe, MD, MSc, interim chair of the department of psychiatry at Brigham and Women’s Hospital, analyzed available data from the OASIS clinical studies, a pair of phase 3 clinical trials designed to assess the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms in women post-menopause. The trials additionally sought clinical outcomes related to sleep disturbances, depressive symptoms and menopause-related quality of life.

“Sleep disturbances associated with menopause are common and bothersome and can impact women’s health and quality of life,” Joffe and colleagues wrote. “However, many women do not attribute their sleep disturbance to menopause and clinicians may not ask about sleep disturbances in counseling.”

In the OASIS trials, women post-menopause experience moderate to severe vasomotor symptoms were randomized 1:1 to elinzanetant 120 mg or placebo for 12 weeks, followed by a 14-week active-treatment phase. A total of 399 patients received elinzanetant, versus 397 patients on placebo, across the 2 trials. The trial investigators had set no threshold for sleep disturbance severity in the inclusion criteria.

Patients received the Patient-Reported Outcomes Measurement Information System (PROMIS-SD-SF-8b) questionnaire electronically at baseline, then weeks 1, 2, 3, 4, then every 4 weeks through the study period, to assess sleep disturbance. The 8-item score interpreted aspects of sleep through qualitative statements including “I was satisfied with my sleep,” and “I had trouble sleeping,” each scored on a 5-point scale. Greater scores interpreted greater sleep disturbance severity.

Baseline mean PROMIS SD-SF-8b total T-scores ranged from 60.2 – 61.7 across the 2 OASIS trials. Investigators noted a majority of participants reported feeling “not at all” or “only a little bit” satisfied with their sleep at baseline, ranging from 69.4% - 78.7%.

The majority of the trials’ cohorts additionally reported having trouble sleeping “often” or “always” at baseline, from 58.1% - 68.6%. Indeed, the investigators concluded that both OASIS trials showed a moderate level of sleep disturbance across all the patient cohorts, on average.

“Most women were unsatisfied with their sleep and reported trouble sleeping,” the team wrote. “These data highlight the high frequency and magnitude of sleep disturbance among postmenopausal women with vasomotor symptoms and support the need for health care providers to address sleep disturbances while counseling.”

References

1. ^{Joffe H, Maki P, Soares CN, Thurston RC, et al. Sleep Disturbance in Menopausal Women with Vasomotor Symptoms: Findings From Two Phase 3 Studies. Paper presented at: Associated Professional Sleep Societies (SLEEP) 2024 Annual Meeting. Houston, TX. June 1 – 5, 2024.}
2. ^{Pinkerton JV, Simon J, Panay N, et al. Design of OASIS 1 and 2: phase 3 clinical trials assessing the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause. Menopause. 2024;31(6):522-529. doi:10.1097/GME.0000000000002350}