O030 Impact of lemborexant on daytime sleepiness/alertness in participants with comorbid insomnia and mild obstructive sleep apnea
Bibliographic record
Abstract
Abstract Introduction Comorbid insomnia with obstructive sleep apnea (COMISA) is associated with daytime functioning and cognitive impairments. Some sleep-promoting medications cause residual morning sleepiness, potentially exacerbating daytime impairment. This post-hoc analysis assessed the impact of lemborexant (LEM), a competitive dual orexin-receptor antagonist approved to treat insomnia in adults, on morning sleepiness/alertness in participants with COMISA. Methods Data from a subgroup of adults (≥55 years) with comorbid insomnia and mild OSA (apnea-hypopnea-index, 5 to ≤15 events/h) from Study E2006-G000-304 (NCT02783729), a 1-month, randomized study, were analyzed (N=410). Participants received placebo (PBO), LEM 5mg (LEM5), LEM 10mg (LEM10), or zolpidem tartrate 6.25mg (not reported). A daily sleep diary assessed morning sleepiness/alertness rated from 1 (extremely sleepy) to 9 (extremely alert). The percentage of participants shifting from baseline mild/moderate sleepiness (≤3) towards greater alertness (4, 5, or >5) during the first and last 7 mornings of the study was analyzed. Results At baseline, 17/75 (22.7%), 36/112 (32.1%), and 28/104 (26.9%) participants with COMISA receiving PBO, LEM5, or LEM10, respectively, reported mild/moderate sleepiness. Of these participants, a greater percentage shifted from mild/moderate sleepiness towards alertness with LEM5 (66.7%, 82.9%) and LEM10 (64.3%, 75.0%) versus PBO (47.1%, 64.7%) across the first and last 7 mornings, respectively. Discussion The sample size was too small to detect statistical differences; however, a greater percentage of participants with COMISA experienced improvements in morning sleepiness across the treatment period with LEM versus PBO. These data align with previous findings that LEM does not affect tasks requiring morning alertness.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".