No Daytime Grogginess Observed With Menopause Hot Flash Drug

TL;DR

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A pooled post-hoc analysis of two phase III trials found that postmenopausal women taking elinzanetant had slightly greater reductions in reported daytime sleepiness than those taking placebo over 12 weeks. The exploratory findings suggest bedtime dosing did not cause next-day sleepiness, but they do not establish that the drug improves alertness or daytime functioning.

A pooled, post-hoc analysis of two phase III trials found no increase in reported daytime sleepiness among postmenopausal women taking the bedtime hot-flash drug elinzanetant over 12 weeks; sleepiness scores fell slightly more than with placebo. The exploratory findings, presented by Claudio Soares at the Menopause Society annual meeting on October 23, address concern that a medicine taken at night could leave patients drowsy the next day, but they do not prove improved daytime functioning.

Soares, of Queen’s University School of Medicine in Kingston, Ontario, and colleagues analyzed data from the OASIS I and OASIS II trials. They compared changes from baseline to week 12 in participants’ reported sleepiness, using seven-day averages and separate scores for morning, afternoon and evening. The scale ranged from 0, not sleepy, to 4, very sleepy.

Mean total sleepiness scores fell by 0.61 points in the elinzanetant group and 0.46 points with placebo, a mean difference of −0.15 points (unadjusted 95% confidence interval −0.27 to −0.02). Morning scores fell by 0.66 and 0.39 points, respectively, a difference of −0.27. Afternoon scores fell by 0.60 with elinzanetant and 0.45 with placebo; evening changes were nearly the same, at −0.56 and −0.54.

The researchers described the work as an exploratory post-hoc analysis, meaning it examined existing trial data rather than reporting a trial designed primarily to test next-day alertness. The reported confidence intervals were unadjusted. The results therefore indicate that participants did not report greater sleepiness on average in the measured period; they are not direct proof that the medicine has no effect on every person’s alertness or ability to function.

Why Next-Day Alertness Matters

Nighttime medicines that affect sleep can raise concerns about residual drowsiness, which may matter for work, driving and other daytime activities. The analysis offers some reassurance for people prescribed elinzanetant for menopause-related vasomotor symptoms: in these trial data, reported sleepiness did not worsen relative to placebo and scores declined slightly more on several measures.

The distinction between a group average and an individual response matters. These findings do not guarantee that no patient will feel sleepy, nor do the sleepiness scores directly establish driving safety or performance. The potential relevance is that treatment of hot flashes and related sleep disruption may not necessarily come with increased self-reported daytime sleepiness, based on this analysis.

Trial Data Behind the Analysis

Elinzanetant, marketed as Lynkuet, is a nonhormonal antagonist of neurokinin-1 and neurokinin-3 receptors. 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. Although it is recommended to be taken at bedtime, it is not indicated as a treatment for sleep disturbance.

In OASIS I and II, the treatment was reported to reduce hot-flash frequency and severity and to improve sleep disturbance and menopause-related quality of life. In the pooled analysis, baseline mean sleepiness scores were 2.04 for participants assigned elinzanetant and 1.94 for those assigned placebo. Baseline PROMIS sleep-disturbance T-scores were 61.4 and 60.5, respectively, which the report characterized as moderate sleep disturbance.

At week 12, PROMIS sleep-disturbance scores had fallen by 10.7 points in the elinzanetant group and 5.3 points with placebo; the reported comparison had P<0.0001. Those results concern sleep disturbance, a separate measure from the daytime sleepiness analysis. A previous phase I study also found no clinically relevant next-morning residual effect on simulated driving performance, according to the report, but that is a distinct study and does not make the current analysis a driving-safety trial.

“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, speaking to MedPage Today

Limits of the Sleepiness Findings

The analysis was post hoc and exploratory, and the source report does not provide the sample size, detailed participant characteristics, or information on how missing sleepiness reports were handled. It also does not describe a prespecified statistical testing plan for these comparisons. The reported confidence intervals are unadjusted, so the findings should be read as signals from existing trial data rather than definitive evidence about next-day alertness.

It remains unclear whether the small differences in sleepiness scores are noticeable or meaningful to patients in daily life. The analysis does not show that elinzanetant improves alertness, nor does it establish that every patient can take it without drowsiness. Detailed results from the long-term OASIS III trial have not yet been presented in the source report.

Long-Term Trial Results Awaited

Soares and colleagues said they plan to present data from the long-term OASIS III trial at a later date, with similar trends in sleepiness reported by the researchers. That presentation may provide further information on sleepiness over longer use, although details and timing were not specified in the report.

Until those data are available, the reported 12-week analysis remains the evidence presented for daytime sleepiness in this report. Patients with questions about elinzanetant, its bedtime dosing or possible side effects should discuss them with a qualified health professional.

Key Questions

What did the analysis find about next-day sleepiness?

Across 12 weeks, average reported sleepiness scores fell slightly more among participants taking elinzanetant than among those taking placebo. The analysis did not find an increase in average daytime sleepiness with the drug.

Was the study designed specifically to test alertness?

No. Researchers conducted a post-hoc exploratory analysis of data from OASIS I and II. It assessed reported sleepiness scores; it was not a trial primarily designed to test alertness or everyday performance.

Is elinzanetant a sleep medicine?

The source report says elinzanetant is approved for moderate to severe menopause-related vasomotor symptoms and is recommended at bedtime. It is not indicated as a treatment for sleep disturbance.

Does this mean no one will feel drowsy?

No. The results describe average scores in trial participants and do not guarantee an individual response. The analysis also did not directly establish that every patient will avoid drowsiness or have unchanged daytime functioning.

What additional evidence is expected?

The researchers said they will present findings from the longer-term OASIS III trial at a later date. The source report did not give a presentation date or further details.

Source: rss