TL;DR
A pooled, post-hoc analysis of the OASIS I and II phase III trials found that postmenopausal women taking bedtime elinzanetant had slightly larger reductions in reported daytime sleepiness than those taking placebo over 12 weeks. The exploratory findings do not establish that the drug cannot cause sleepiness in individual patients or prove an effect on daytime functioning.
A pooled post-hoc analysis of two phase III trials found that postmenopausal women taking bedtime elinzanetant had modestly greater reductions in reported daytime sleepiness over 12 weeks than women taking placebo, researchers reported at the Menopause Society annual meeting on October 23. The exploratory results suggest the medicine did not increase next-day sleepiness scores in the study, addressing a concern about daytime effects when a drug is taken at night.
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The analysis used data from OASIS I and OASIS II, trials of elinzanetant, a nonhormonal medicine that blocks neurokinin-1 and neurokinin-3 receptors. Researchers calculated seven-day average scores on a sleepiness scale ranging from 0, not sleepy, to 4, very sleepy, comparing changes from participants’ baseline scores to week 12.
Mean total sleepiness scores fell by 0.61 points with elinzanetant and 0.46 points with placebo. The unadjusted mean difference was -0.15 points, with a 95% confidence interval from -0.27 to -0.02. Morning scores fell by 0.66 points in the elinzanetant group and 0.39 points with placebo; the difference was -0.27 points (unadjusted 95% confidence interval -0.42 to -0.13).
Afternoon scores decreased by 0.60 points with elinzanetant and 0.45 with placebo, a difference of -0.15 points. Evening scores changed by -0.56 and -0.54 points, respectively, with a difference of -0.02 points and a confidence interval that included no difference. Researchers also reported improvement in sleep-disturbance scores at week 12: a reduction of 10.7 points with elinzanetant compared with 5.3 points with placebo (P<0.0001).
Daytime Effects After Bedtime Dosing
Sleep disruption and hot flashes can occur together during menopause, and a medicine taken at night may raise concerns about residual sleepiness the next day. The reported analysis addresses that practical question for people considering elinzanetant for moderate to severe menopause-related vasomotor symptoms. The average sleepiness scores declined in both groups, with somewhat larger reductions for elinzanetant on total, morning and afternoon measures.
Those results are relevant, but they do not show that every patient will feel more alert or that the medicine improves daytime functioning in all circumstances. The differences between groups were modest on the sleepiness scale, and the analysis was exploratory. The findings should be read alongside the broader evidence on effectiveness and safety, not as a guarantee that no individual will experience sleepiness.
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OASIS Trials and Menopause Symptoms
Elinzanetant, marketed as Lynkuet, is a nonhormonal dual neurokinin receptor antagonist. The OASIS I and II trials examined its effects on menopause-related vasomotor symptoms, commonly known as hot flashes. The source report says the trials found reductions in hot-flash frequency and severity, as well as improvements in sleep disturbance and menopause-related quality of life. The U.S. Food and Drug Administration approved elinzanetant for moderate to severe vasomotor symptoms due to menopause.
The medicine is recommended to be taken at bedtime, but the analysis described here was not a trial designed primarily to test daytime alertness. Researchers retrospectively pooled sleepiness data from the two studies and compared changes over 12 weeks. The report also notes that an earlier phase I study found no clinically relevant next-morning residual effect on simulated driving performance; that finding comes from a separate study and is not a real-world driving assessment.
“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
Limits of the Sleepiness Analysis
The findings come from a post-hoc exploratory analysis, rather than a study designed in advance to establish whether elinzanetant causes next-day sleepiness. The source report does not provide the number of participants included in this pooled analysis, detailed results by participant subgroup, or information about how many individuals experienced worsening sleepiness. Group averages can conceal variation between patients.
The reported confidence intervals are described as unadjusted, and the analysis assessed scale scores rather than directly measuring every form of daytime alertness or function. It remains unclear from the available report whether the changes are meaningful to patients in everyday life. The findings also do not establish that sleepiness is impossible, or replace the full prescribing information and safety discussion between patients and clinicians.
Longer-Term OASIS Data Ahead
Soares and colleagues said data from the long-term OASIS III trial, which they described as showing similar trends in improved sleepiness, will be presented at a later date. That future presentation may add information about whether the pattern persists beyond the 12-week period covered in this analysis. No presentation date or additional numerical results were provided in the source report.
For now, the available finding is limited to the reported changes in sleepiness scores from OASIS I and II. Further assessment would be needed to clarify the durability and everyday significance of the effect and how individual patients respond.
Key Questions
What did the analysis find about next-day sleepiness?
Across 12 weeks, average total sleepiness scores decreased by 0.61 points with elinzanetant and 0.46 points with placebo. The exploratory analysis did not find an increase in group-level sleepiness scores with the bedtime medicine.
Was the study specifically designed to test daytime grogginess?
No. Researchers conducted a pooled post-hoc exploratory analysis of data from OASIS I and II. They examined sleepiness scores collected during the trials rather than reporting a trial designed primarily to test next-day alertness.
What is elinzanetant used for?
Elinzanetant is a nonhormonal medicine used for moderate to severe vasomotor symptoms due to menopause, including hot flashes. The source report says it is recommended to be taken at bedtime.
Does this mean no patient will feel sleepy after taking it?
No. The analysis reports average scores and cannot rule out sleepiness in an individual. The findings are exploratory and do not guarantee how any one person will respond.
What evidence is expected next?
The researchers said results from the longer-term OASIS III trial, which they described as showing similar sleepiness trends, will be presented later. The report did not give a date or the study’s numerical results.
Source: rss
