Consistency of objective and subjective evidence for the efficacy of lemborexant
Bibliographic record
Abstract
Objectives To review the efficacy of lemborexant (LEM), a dual orexin-receptor antagonist approved in multiple countries for treatment of insomnia in adults, by assessing the consistency of the available LEM objective and subjective evidence.Methods Data from 2 pivotal phase 3, randomized, double-blind, parallel-group, placebo (PBO)-controlled studies are reviewed. Study 304 (1-month) and Study 303 (12-months; only first 6 months included here) evaluated the efficacy/safety of LEM 5 mg (LEM5) and LEM 10 mg (LEM10) in adults with insomnia disorder. Objective sleep onset (latency to persistent sleep [LPS]) and sleep maintenance (wake after sleep onset [WASO] and total sleep time [TST]) were assessed with polysomnography in Study 304. Subjective sleep onset latency (sSOL) and sleep maintenance (sWASO and sTST) were assessed with sleep diaries in both studies. Other patient-reported efficacy measures included Insomnia Severity Index-total score (ISI-TS), ISI-daytime functioning (ISI-DF), Fatigue Severity Scale (FSS), and Patient Global Impression-Insomnia (PGI-I).Results Compared with PBO, significantly larger decreases (improvements) from baseline in LPS, sSOL, WASO, and sWASO and significantly larger increases (improvements) from baseline in TST and sTST were observed within the first week of LEM treatment (as early as within the first 1–2 nights) and were sustained throughout the treatment period (1–6 months) (all p < 0.05, except for sWASO at Month 1). These improvements aligned with significantly larger decreases (improvements) from baseline in ISI-TS, ISI-DF, and PGI-I (all p < 0.05). Significantly larger decreases (improvement) from baseline in FSS scores were observed at 3 and 6 months (both p < 0.05).Conclusion LEM showed concordance in its ability to improve objective and subjective measures of nighttime sleep, as well as daytime functioning and patient perception of nighttime sleep. These findings demonstrate that LEM is effective both objectively and from the patient’s perspective, supporting LEM as a valuable treatment option for adults with insomnia.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.055 | 0.170 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.008 | 0.006 |
| Bibliometrics | 0.007 | 0.004 |
| Science and technology studies | 0.000 | 0.003 |
| Scholarly communication | 0.005 | 0.003 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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 source (direct Gemma or distilled Codex), 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".