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A pooled post-hoc analysis of the OASIS I and II phase III trials found that women taking bedtime elinzanetant had slightly greater reductions in reported daytime sleepiness scores than those taking placebo over 12 weeks. The exploratory findings suggest no increase in next-day sleepiness, but do not establish that the drug improves alertness or prove an absence of effects for every patient.
A pooled, post-hoc analysis of two phase III trials found that postmenopausal women taking elinzanetant at bedtime reported slightly greater reductions in daytime sleepiness scores over 12 weeks than women taking placebo. The results, presented by Claudio Soares at the Menopause Society annual meeting, address a concern that an evening medication used for menopause symptoms might leave patients groggy the next day; they do not prove that no individual patient experiences sleepiness.
Researchers combined data from the OASIS I and OASIS II trials to examine daytime sleepiness among participants taking elinzanetant or placebo. The analysis used seven-day averages of Sleepiness Scale scores, with responses ranging from 0, not sleepy, to 4, very sleepy. Investigators compared average total scores and morning, afternoon and evening scores from baseline to week 12.
Mean total sleepiness scores fell by 0.61 points with elinzanetant and 0.46 with placebo, a mean difference of -0.15 (unadjusted 95% confidence interval, -0.27 to -0.02). Morning scores fell by 0.66 and 0.39 points, respectively; afternoon scores fell by 0.60 and 0.45. The evening difference was smaller: scores declined by 0.56 with elinzanetant and 0.54 with placebo, with a mean difference of -0.02 (unadjusted 95% confidence interval, -0.16 to 0.12).
The report also cited a reduction in sleep-disturbance scores at week 12: the mean PROMIS Sleep Disturbance score decreased by 10.7 points in the elinzanetant group, compared with 5.3 points with placebo (P<0.0001). The trial groups' baseline mean Sleepiness Scale scores were 2.04 and 1.94, while baseline PROMIS scores indicated moderate sleep disturbance. These are group averages, not a guarantee about an individual patient's response.
Daytime Alertness After Bedtime Dosing
People considering medication for menopause-related hot flashes may be concerned that taking a drug at night could impair alertness the following day. The analysis offers reassuring, but limited, evidence: on average, participants taking elinzanetant did not report a rise in daytime sleepiness, and their scores declined somewhat more than those of placebo recipients.
That matters because the treatment is recommended at bedtime while targeting moderate to severe vasomotor symptoms, such as hot flashes. Sleep effects and next-day functioning can influence whether patients find a treatment acceptable. However, the results are exploratory and based on self-reported scale scores. They should not be read as proof that the drug improves daytime functioning, eliminates grogginess, or has no relevant side effects.
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OASIS Trials and Menopause Treatment
Elinzanetant, marketed as Lynkuet, is a nonhormonal dual neurokinin receptor antagonist. The source report says the U.S. Food and Drug Administration approved it for moderate to severe menopause-related vasomotor symptoms following results from the OASIS program. In OASIS I and II, the drug reduced hot-flash frequency and severity and was also associated with reduced sleep disturbance and improved menopause-related quality of life.
The current presentation examined a different question from the trials’ main symptom outcomes: whether bedtime dosing was associated with residual sleepiness the next day. The analysis was conducted after the trials, rather than being described as a primary trial endpoint. A previous phase I study also suggested no clinically relevant next-morning residual effect on simulated driving performance, according to the report; that finding is separate from the phase III sleepiness analysis.
“Patients treated with this medication, hoping to improve their vasomotor symptoms and sleep problems, can be reassured that they are unlikely to experience sleepiness the next day as an undesired, residual effect.”
— Claudio Soares, MD, PhD, of Queen’s University School of Medicine, speaking to MedPage Today
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Limits of the Sleepiness Analysis
The findings come from a post-hoc exploratory analysis, and the report provides no evidence that next-day sleepiness was the primary outcome the original phase III trials were designed to test. The reported confidence intervals are unadjusted, and the available account does not explain whether the analysis accounted for multiple comparisons across total and time-of-day scores. The numerical differences were modest, and their practical importance for patients is not established by the figures alone.
The results also do not show how sleepiness may vary among individuals, whether particular patient groups are more likely to experience it, or how the findings translate into objective measures of daily performance. The source reports a prior simulated-driving study but does not provide its detailed methods or results. Patients should discuss medication questions and any sleepiness or other side effects with a qualified clinician.
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Longer-Term OASIS Results Pending
Soares and colleagues said they plan to present data from the longer-term OASIS III trial at a later date, with similar trends in improved sleepiness reported by the researchers. The source material does not give a presentation date or provide those trial results, so the longer-term findings remain pending.
Until further results are available, the 12-week analysis offers a limited view of daytime sleepiness in the two placebo-controlled trial datasets. Any assessment of how the drug affects an individual patient’s alertness, sleep and daily activities will require consideration of the full clinical evidence and the patient’s circumstances.
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Key Questions
Did the analysis find that elinzanetant causes no daytime grogginess?
It found that average reported sleepiness scores declined over 12 weeks among participants taking elinzanetant, rather than increasing compared with placebo. Because this was a group-level post-hoc analysis, it cannot rule out sleepiness for an individual patient.
How large were the differences from placebo?
The mean difference in change in total sleepiness score was -0.15 points in favor of elinzanetant. The largest reported time-of-day difference was in the morning, at -0.27 points. Scores used a 0-to-4 scale, and the analysis does not establish how meaningful these differences are in everyday life.
Was the drug studied as a treatment for sleep problems?
The report says elinzanetant is approved for moderate to severe vasomotor symptoms due to menopause, not indicated specifically for sleep disturbance. The analysis examined sleepiness and sleep-related measures using data from the OASIS I and II trials.
What evidence is expected next?
The researchers said OASIS III long-term data, which they described as showing similar trends in sleepiness, would be presented later. The source does not specify when those results will be available.
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