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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 the drug did not cause residual next-day sleepiness, but they do not establish that it improves sleepiness for every patient.
A pooled post-hoc analysis of two phase III trials found no increase in next-day sleepiness among postmenopausal women taking elinzanetant at bedtime for menopause-related hot flashes; average sleepiness scores fell slightly more than with placebo over 12 weeks. The exploratory findings, presented by Claudio Soares at the Menopause Society annual meeting, address a potential concern about taking a medication in the evening, but do not prove that every patient will avoid daytime drowsiness.
Soares, of Queen’s University School of Medicine in Kingston, Ontario, and colleagues analyzed data from the OASIS I and OASIS II trials. They calculated seven-day averages for total and time-of-day sleepiness scores, comparing changes from baseline to week 12. The scale ranged from 0, not sleepy, to 4, very sleepy.
Mean total sleepiness scores fell by 0.61 points with elinzanetant and 0.46 points with placebo, a mean difference of 0.15 points favoring the drug. Morning scores fell by 0.66 points with elinzanetant and 0.39 with placebo. Afternoon scores also declined somewhat more with elinzanetant; evening changes were similar between groups. The reported confidence intervals were unadjusted.
The analysis also reported improved sleep-disturbance scores. At baseline, the average PROMIS Sleep Disturbance score was 61.4 in the elinzanetant group and 60.5 in the placebo group, levels the researchers described as moderate sleep disturbance. By week 12, scores had fallen by 10.7 points with elinzanetant and 5.3 points with placebo (P<0.0001). These results concern reported scores, not a direct demonstration that the medication prevents sleepiness in every individual.
Daytime Alertness After Bedtime Dosing
Elinzanetant is taken at bedtime, and a concern with medicines used in the evening is that lingering effects could leave people sleepy the following day. That issue can matter to patients’ daily routines and functioning, especially for those seeking relief from hot flashes alongside sleep problems. The analysis offers evidence against an average increase in daytime sleepiness in these trial data.
The difference between groups was small on the sleepiness scale, and the analysis was exploratory. It should not be read as a guarantee of alertness or as a direct assessment of every activity, such as driving. Patients who feel drowsy after taking a medication should discuss it with a health professional rather than relying on group averages.
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OASIS Trials and Menopause Treatment
Elinzanetant, marketed as Lynkuet, is a nonhormonal antagonist of NK1 and NK3 receptors. The OASIS I and II trials evaluated it in postmenopausal women with moderate to severe vasomotor symptoms, including 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.
On the basis of those results, the U.S. Food and Drug Administration approved elinzanetant for moderate to severe vasomotor symptoms due to menopause. It is recommended for bedtime use, but is not indicated as a treatment for sleep disturbance. The new presentation focuses on whether bedtime dosing was associated with sleepiness the next day, rather than on establishing a separate sleep indication.
A previous phase I study, as described in the report, found no clinically relevant next-morning residual effect on simulated driving performance. That earlier finding and the current questionnaire analysis address related concerns, but they are different kinds of evidence and do not amount to a broad guarantee about real-world driving or alertness.
“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 Analysis
The analysis was post hoc and exploratory, meaning the researchers examined existing trial data to address a question rather than reporting a standalone trial designed specifically to test next-day alertness. The source report does not provide the participant count for this pooled analysis, details about adjustment for multiple comparisons, or evidence that the score differences translate into a noticeable change in everyday functioning.
The results describe average changes over 12 weeks and cannot rule out sleepiness in particular patients. The reported confidence intervals were unadjusted, and the study relied on sleepiness ratings rather than a comprehensive set of objective daytime performance measures. The findings also do not establish that elinzanetant should be used to treat sleep disturbance.
Researchers said results from the longer-term OASIS III trial showed similar trends in sleepiness, but those data had not yet been presented. The size and details of that evidence, and whether it will alter the interpretation of the shorter-term analysis, remain unknown.
Longer-Term OASIS III Results
Soares and colleagues said data from the long-term OASIS III trial, which they described as showing similar trends in improved sleepiness, would be presented at a later date. The source report did not specify a presentation date or provide the trial’s numerical results.
Until those findings are available, the current results remain a 12-week, exploratory analysis of OASIS I and II data. Patients considering or taking elinzanetant can ask their prescriber about expected effects, bedtime dosing and any sleepiness they experience; the analysis does not replace individual medical advice.
Key Questions
What did the analysis find about next-day sleepiness?
Average sleepiness scores declined in both groups over 12 weeks, with slightly larger reductions among participants taking elinzanetant than among those taking placebo. The researchers interpreted this as evidence that bedtime dosing did not increase average next-day sleepiness in the analyzed data.
Was elinzanetant tested as a sleep medicine?
No. The report says elinzanetant is approved for moderate to severe menopause-related vasomotor symptoms and is not indicated to treat sleep disturbance. The analysis examined sleepiness and sleep-related outcomes within data from hot-flash trials.
How large were the sleepiness-score differences?
At week 12, mean total sleepiness scores had changed by −0.61 points with elinzanetant and −0.46 with placebo, a mean difference of −0.15. Morning and afternoon scores also fell somewhat more with elinzanetant, while evening changes were similar.
Does this mean no patient will feel drowsy?
No. These are average results from an exploratory analysis, not a guarantee about individual responses. Anyone experiencing daytime drowsiness or other concerning effects should contact their prescriber.
What evidence is expected next?
The researchers said longer-term OASIS III results, which they reported showed similar trends, would be presented later. No presentation date or detailed results were included in the report.
Source: rss
