TL;DR
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A pooled post-hoc analysis of two phase III trials found that postmenopausal women taking bedtime elinzanetant reported slightly greater reductions in daytime sleepiness than women taking placebo over 12 weeks. The exploratory findings suggest no next-day grogginess signal, but do not establish that the drug treats sleep problems or prove the result across all patients.
A pooled post-hoc analysis of two phase III trials found that postmenopausal women taking the menopause hot-flash drug elinzanetant at bedtime did not report greater daytime sleepiness than women taking placebo over 12 weeks. The exploratory findings, presented by Claudio Soares at the Menopause Society annual meeting, address a concern that a medicine taken at night could leave patients groggy the following day.
Researchers analyzed data from the OASIS I and OASIS II trials, comparing changes in reported sleepiness from baseline to week 12. Sleepiness was recorded on a scale from 0, not sleepy, to 4, very sleepy, using seven-day averages for total, morning, afternoon and evening scores. Average baseline scores were 2.04 for participants assigned elinzanetant and 1.94 for those assigned placebo.
The mean total score fell by 0.61 points with elinzanetant and 0.46 points with placebo, a difference of 0.15 points. Morning scores fell by 0.66 and 0.39 points, respectively; afternoon scores fell by 0.60 and 0.45. Evening scores changed by 0.56 points with elinzanetant and 0.54 with placebo. The reported confidence intervals for the between-group differences were unadjusted.
The analysis also reported improvement in a separate measure of sleep disturbance. At week 12, the mean score on the PROMIS Sleep Disturbance Short Form had declined by 10.7 points in the elinzanetant group and 5.3 points in the placebo group (P<0.0001). These results concern reported sleepiness and sleep disturbance; they do not establish that elinzanetant is a treatment for sleep disorders.
Daytime Alertness and Bedtime Dosing
The findings address a practical concern for people taking a medication at night to manage menopause symptoms: whether it could affect alertness the next day. In this analysis, sleepiness scores improved rather than worsened on average, with the largest reported difference between groups in the morning. That may help inform discussions about the medicine’s effects, alongside its intended use and known safety information.
The result is not proof that every patient will avoid grogginess. It comes from an exploratory analysis of trial data, and the average differences were modest. Nor does the analysis show that improved sleepiness scores translate into better driving, work performance or other daytime functioning. Those are separate outcomes that require appropriate evidence.
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How the OASIS Trials Fit
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 vasomotor symptoms associated with menopause, including hot flashes. It is recommended to be taken at bedtime, though the drug is not indicated as a treatment for sleep disturbance.
In OASIS I and II, the treatment reduced the frequency and severity of hot flashes and was also associated with reduced sleep disturbance and improved menopause-related quality of life. The current report examines a narrower question using data from those trials: whether bedtime dosing was associated with residual sleepiness during the day. A previous phase I study was also described as finding no clinically relevant next-morning residual effect on simulated driving performance, but that was a different study and outcome.
“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
This was a post-hoc exploratory analysis, meaning researchers examined sleepiness outcomes using data from trials designed to study menopause symptoms. The supplied report does not give the number of participants included in this pooled analysis, detailed subgroup results, or adjusted confidence intervals for the reported score differences. The total, morning and afternoon between-group confidence intervals were reported as unadjusted; the evening interval included no difference.
The results describe group averages over 12 weeks and cannot show how an individual patient will respond. The report also does not provide evidence that the score changes prevent real-world impairment, or establish whether findings differ by age, dose, other medicines or medical conditions. The long-term OASIS-III results have not yet been presented, according to the investigators.
Long-Term Trial Results Awaited
Soares and colleagues said they plan to present data from the longer-term OASIS-III trial at a later date, with similar trends in sleepiness reported by the researchers. Those findings may add information about whether the pattern continues over a longer period, although the source material does not provide a presentation date or full results.
For now, the reported analysis supports a limited conclusion: average daytime sleepiness scores did not worsen with bedtime elinzanetant in the two trials over 12 weeks. Readers considering the medicine should rely on its approved prescribing information and discuss questions about benefits, side effects and personal circumstances with a qualified health professional.
Key Questions
What did the analysis find about next-day grogginess?
Across 12 weeks, participants assigned elinzanetant had slightly larger average reductions in reported sleepiness than those assigned placebo. The analysis did not find an increase in daytime sleepiness at the group level.
Is elinzanetant approved to treat sleep problems?
No. The source report says elinzanetant is approved for moderate to severe menopause-related vasomotor symptoms. It is recommended at bedtime, but is not indicated as a treatment for sleep disturbance.
How strong is the evidence?
The findings come from a pooled post-hoc exploratory analysis of two phase III trials. They report average questionnaire scores and do not guarantee an individual will avoid sleepiness or establish effects on every aspect of daytime functioning.
What results are expected next?
The researchers said long-term results from OASIS-III, which they described as showing similar sleepiness trends, will be presented later. No date or full data were provided in the source report.
Source: rss
