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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 did not report increased daytime sleepiness over 12 weeks. Sleepiness scores fell more than with placebo, but the analysis was exploratory and does not establish that the drug improves sleepiness for every patient.
A pooled post-hoc analysis of two phase III trials found no sign that bedtime elinzanetant increased next-day sleepiness in postmenopausal women treated for menopause-related hot flashes. The analysis, presented by Claudio Soares at the Menopause Society annual meeting, found that participants’ sleepiness scores decreased over 12 weeks, with somewhat larger average reductions in the elinzanetant group than in the placebo group.
Researchers used data from the OASIS I and OASIS II trials to examine whether taking elinzanetant in the evening was followed by residual daytime sleepiness. The drug, sold as Lynkuet, is a nonhormonal antagonist of the NK1 and NK3 neurokinin receptors. The analysis measured seven-day average sleepiness scores at baseline and week 12, on a scale from 0, not sleepy, to 4, very sleepy.
Average total scores changed by -0.61 with elinzanetant and -0.46 with placebo, a mean difference of -0.15. Morning scores fell by 0.66 and 0.39, respectively; afternoon scores fell by 0.60 and 0.45. Evening scores changed by -0.56 with elinzanetant and -0.54 with placebo. The reported confidence intervals for the total, morning and afternoon differences excluded zero, while the evening difference was small and its interval included zero. The analysis reported unadjusted 95% confidence intervals.
At baseline, average sleepiness scores were 2.04 in the elinzanetant group and 1.94 in the placebo group. Participants also had moderate sleep disturbance on a separate measure. By week 12, the PROMIS Sleep Disturbance score had fallen by 10.7 points with elinzanetant and 5.3 with placebo; the report gave P<0.0001 for that comparison. These sleep-disturbance results are distinct from the daytime sleepiness scores.
Next-Day Alertness After Bedtime Dosing
The findings address a practical concern for people taking a medicine at bedtime: whether its effects may carry into the following day. A treatment that helps menopause-related symptoms or sleep could be less acceptable if it also leaves patients drowsy during daytime activities. In this analysis, the average scores did not show that pattern; they fell in both groups, with larger reductions in the elinzanetant group on the total, morning and afternoon measures.
The results are relevant to counseling about daytime functioning, but they do not prove that no individual will feel sleepy after taking the drug. Group averages can conceal differences among participants, and the analysis was not a dedicated trial designed primarily to test alertness. The score changes also should not be treated as evidence that elinzanetant is a sleep medication: the source report says it is not indicated for sleep disturbance, even though it is taken at bedtime and prior trials reported improvements in sleep-related measures.
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OASIS Trials and the Sleepiness Measure
Elinzanetant was studied in the OASIS program for moderate to severe vasomotor symptoms, including hot flashes associated with menopause. The source report says the FDA approved the drug for that indication based on trial results showing reductions in hot-flash frequency and severity, along with improvements in sleep disturbance and menopause-related quality of life. Its bedtime dosing made next-day effects a question researchers chose to examine.
This report covers a post-hoc exploratory analysis, meaning the investigators examined existing trial data for an additional question rather than reporting a trial designed specifically around daytime sleepiness. Soares and colleagues calculated average scores across the week for total sleepiness and for morning, afternoon and evening periods. MedPage Today also reported that an earlier phase I study found no clinically relevant next-morning residual effect on simulated driving performance; that finding is separate from the phase III questionnaire 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 Exploratory Findings
The analysis does not establish whether every patient avoids daytime sleepiness, nor does it show how the scores translate into performance in daily tasks for individual users. It was post hoc and exploratory, and the reported sleepiness comparisons used unadjusted confidence intervals. The source report does not provide the number of participants included in this specific analysis or detailed results by age, other medications or health conditions.
The findings also do not settle whether the score differences are meaningful to patients in everyday life. Although the researchers reported improved sleep-disturbance scores in the trial data, that outcome is not the same as next-day alertness, and elinzanetant is not indicated as a treatment for sleep disturbance. Further details, including the planned long-term OASIS-III results, have not yet been reported in the source material.
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Long-Term OASIS-III Results Pending
Soares and colleagues said data from the long-term OASIS-III trial, which they said show similar trends in sleepiness, will be presented at a later date. The source report did not give a presentation date or provide the underlying OASIS-III figures. Those results may add information about whether the pattern seen over 12 weeks continues with longer follow-up, but readers will need the full data to assess the scale and reliability of any effect.
For now, the reported finding is limited to the pooled analysis of OASIS I and II: average daytime sleepiness scores did not worsen with bedtime elinzanetant compared with placebo over 12 weeks. The analysis does not replace individualized medical advice or the drug’s prescribing information.
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Key Questions
What did the analysis find about daytime sleepiness?
In a pooled post-hoc analysis of OASIS I and II, average total, morning and afternoon sleepiness scores fell more with elinzanetant than with placebo over 12 weeks. The results did not show increased average daytime sleepiness from bedtime dosing.
Is elinzanetant a sleep medicine?
No. The source report says elinzanetant is not indicated for sleep disturbance. It is approved for moderate to severe menopause-related vasomotor symptoms, and the sleep-related findings were additional outcomes reported in the trials.
Does the result mean no one will feel sleepy the next day?
No. The analysis reports average scores across groups; it cannot guarantee how a particular person will respond. It was also exploratory and was not primarily designed as a trial of alertness or daily performance.
When will more long-term results be available?
Soares and colleagues said results from the long-term OASIS-III trial would be presented later. The source report did not specify when the presentation will take place.
Source: rss
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