338 How Much Improvement in the Insomnia Severity Index Is Associated With a Positive Impact of A Patient’s Insomnia Medication?
Bibliographic record
Abstract
Abstract Introduction In Phase 3 Study 304 (SUNRISE-1; NCT02783729) and Study 303 (SUNRISE-2; NCT02952820), lemborexant (LEM) provided significant benefit versus placebo on sleep diary-based sleep onset/maintenance outcomes over 1mo and 6mo, respectively, in subjects with insomnia disorder. Both studies included the Insomnia Severity Index (ISI) and the Patient Global Impression–Insomnia version (PGI-I). On the PGI-I scale, subjects assess positive, neutral or negative treatment impact on falling asleep, overall benefit on sleep, and total sleep time. Using an anchor-based approach, ratings were compared with mean changes in ISI scores from baseline to evaluate what would be considered a responder definition on the ISI. Methods Study 304 was a 1mo, randomized, double-blind, placebo- and active-controlled, parallel-group study in female (age ≥55y) and male (age ≥65y) subjects (n=1006); subjects received placebo, LEM 5mg, LEM 10mg, or zolpidem tartrate extended-release. Study 303 was a 12mo, randomized, double-blind study in subjects age ≥18y (n=950). Subjects received placebo, LEM 5mg, or LEM 10mg for 6mo. Data from both studies were pooled for the first month of treatment across all treatment groups. A modified ISI total score (ISI-ts) was used based on a confirmatory factor analysis that showed no incremental value to including Question 5 (How NOTICEABLE to others do you think your sleep problem is in terms of impairing the quality of your life?). Results The ‘Overall Sleep’ PGI-I item demonstrated that mean [SD] changes from baseline in ISI-ts decreased more in association with self-reported positive effects (−8.15 [4.98]) than for neutral (−3.59 [3.37]) or negative effects (−1.67 [2.91]) at Day 31/Month 1. For PGI-I Item ‘Time to Fall Asleep,’ mean (SD) changes from baseline in ISI-ts were −7.49 (5.10) for positive, −4.54 (4.13) for neutral, and −2.94 (4.04) for negative effects at Day 31/Month 1. For PGI-I Item ‘Total Sleep Time’ mean (SD) changes from baseline in ISI-ts were −8.15 (5.04) for positive, −3.74 (3.23) for neutral, and −2.40 (3.49) for negative effects at Day 31/Month 1. Conclusion Results of this anchor-based approach using the PGI-I suggest that the responder definition for ISI-ts, using the modified ISI, should be approximately −8 points. Support (if any) Eisai Inc.
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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) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 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".