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A pooled post-hoc analysis of the OASIS I and II phase III trials found that postmenopausal women taking bedtime elinzanetant had slightly greater reductions in daytime sleepiness scores than those taking placebo over 12 weeks. The exploratory results suggest no increase in next-day sleepiness, but they do not establish that the drug cannot cause drowsiness in individual patients.
A pooled post-hoc analysis of two phase III trials found that postmenopausal women taking bedtime elinzanetant had slightly greater reductions in reported daytime sleepiness than women taking placebo over 12 weeks, researchers reported October 23 at the Menopause Society annual meeting. The findings suggest the hot-flash treatment did not add next-day sleepiness in the study, though the analysis was exploratory and does not rule out drowsiness for individual patients.
Claudio Soares, MD, PhD, of Queen’s University School of Medicine in Kingston, Ontario, presented results pooled from the OASIS I and OASIS II trials. The analysis compared changes from baseline in participants’ Sleepiness Scale scores, which ranged from 0, not sleepy, to 4, very sleepy. Researchers calculated average total scores as well as morning, afternoon and evening scores through week 12.
The mean total score fell by 0.61 points with elinzanetant and 0.46 points with placebo, a mean difference of 0.15 points in favor of the drug. Morning scores declined by 0.66 points with elinzanetant and 0.39 with placebo. Afternoon scores fell by 0.60 and 0.45 points, respectively. Evening changes were nearly the same: 0.56 points with elinzanetant and 0.54 with placebo. The reported confidence intervals were unadjusted.
The report also described improvement in sleep disturbance. At baseline, mean scores on the PROMIS Sleep Disturbance Short Form were 61.4 in the elinzanetant group and 60.5 in the placebo group, levels the researchers characterized as moderate sleep disturbance. By week 12, scores had declined by 10.7 points with elinzanetant and 5.3 with placebo (P<0.0001). These sleep-disturbance results are separate from the daytime sleepiness comparison.
Sleep Benefits Without Higher Sleepiness Scores
Sleep disruption and hot flashes can occur together during menopause, and a medicine taken at night may raise concerns about next-day alertness. In this analysis, sleepiness scores did not rise among participants receiving elinzanetant; they fell modestly, with the largest difference from placebo in the morning. That offers relevant information for patients and clinicians weighing potential sleep-related benefits against possible daytime effects.
However, the findings should not be read as proof that no patient will feel sleepy. The average differences were small, the analysis was conducted after the original trials, and the results describe group-level questionnaire scores rather than a guarantee about an individual’s response or ability to drive. The data address one potential side effect, not every safety consideration associated with treatment.
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How the OASIS Trials Inform the Analysis
Elinzanetant, marketed as Lynkuet, is a nonhormonal medicine that blocks NK1 and NK3 receptors. The original OASIS I and II trials studied its effects on menopause-related vasomotor symptoms, commonly called hot flashes. The trials also reported reduced sleep disturbance and improved menopause-related quality of life. The U.S. Food and Drug Administration approved the medicine for moderate to severe vasomotor symptoms due to menopause, according to the source report.
Although it is taken at bedtime, elinzanetant is not indicated as a sleep-disturbance treatment. The researchers examined daytime sleepiness to assess whether evening dosing was associated with a residual effect the following day. A previous phase I study had also suggested no clinically relevant next-morning effect on simulated driving performance, but that is a separate study and does not replace evidence about real-world driving or individual reactions.
“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, speaking to MedPage Today
Limits of the Sleepiness Findings
The analysis was post hoc and exploratory, meaning it examined trial data after the primary studies had been conducted. The report does not establish that daytime sleepiness was a primary outcome in the original trials, nor does it show whether the score differences translate into measurable changes in work, driving or other daily activities. The reported confidence intervals were unadjusted, and the results are averages across groups.
The source report does not provide the number of participants included in this pooled analysis or detailed information about how many individuals experienced meaningful worsening or improvement. It also does not establish how the results apply beyond the 12-week placebo-controlled period. While the study authors said longer-term OASIS III data showed similar trends, those results had not yet been presented.
Longer-Term OASIS III Results Pending
Soares and colleagues said data from the long-term OASIS III trial, which they described as showing similar trends in sleepiness, would be presented at a later date. That presentation may add information about whether the pattern persists beyond the 12-week comparison. Until those data are available, the reported findings remain a short-term, exploratory analysis of OASIS I and II.
People considering or taking elinzanetant should discuss treatment questions and any sleepiness or other symptoms with a qualified health professional. The study results do not replace individualized medical advice or the medicine’s prescribing information.
Key Questions
What did the analysis find about daytime sleepiness?
Across 12 weeks, average sleepiness scores declined slightly more with elinzanetant than with placebo. The largest difference was in morning scores. The analysis did not find an increase in average next-day sleepiness in the treatment group.
Does this mean elinzanetant cannot make someone drowsy?
No. The results describe average scores in a trial analysis and cannot rule out sleepiness or other effects in an individual. The study authors characterized patients as unlikely to experience residual sleepiness, not as unable to experience it.
What is elinzanetant used to treat?
Elinzanetant (Lynkuet) is a nonhormonal medicine approved by the FDA for moderate to severe vasomotor symptoms due to menopause, including hot flashes, according to the source report. It is taken at bedtime but is not indicated as a treatment for sleep disturbance.
How strong is the evidence about sleepiness?
The finding comes from a post-hoc exploratory analysis of two phase III trials, not a standalone study designed to guarantee that no next-day effects occur. Longer-term OASIS III results were said to be forthcoming.
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