ArticleNature and science of sleep2026
Chloral Hydrate in the Treatment of Severe Insomnia When Other Treatments Have Failed: Results From a Real-World Evidence Study (RESTORE).
Article in Nature and science of sleep, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06053840 (An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients with Severe Insomnia), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients with Severe Insomnia
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Study Objectives: The efficacy and safety of chloral hydrate, used as approved for severe insomnia in the UK, were assessed in a single-arm, open-label, real-world, decentralized clinical trial using contemporary self-reported outcome measures. Methods: Participants (18-75 years) had clinically significant impairment by severe insomnia (Insomnia Severity Index (ISI) score of 20-28), and history of behavioral and pharmacological sleep therapy failure. Specialists confirmed the clinical diagnosis and prescribed chloral hydrate (500 mg/5 mL oral solution, 430 or 860 mg daily) for 2 weeks followed by a 4-week follow-up period. Endpoints included change in ISI score from confirmatory diagnosis to treatment end (primary); and sleep measures, health-related quality of life (HRQoL), anxiety, depression, and adverse events (AEs; secondaries). Results: Of the 96 participants (mean baseline ISI, 24.03 [SD, 2.06]), 85 completed the study. Improvements were observed with ISI at treatment end (week 2 mean change was -10.79 [95% confidence interval, -12.12, -9.47]; n=93; week 6 mean change was -8.04 (95% confidence interval, -9.13, -6.95; p < 0.0001; n=85), exceeding the 6-point change considered a minimal clinically important difference. Self-reported sleep measures including Epworth Sleepiness Scale and Pittsburgh Sleep Quality Index, HRQoL, and anxiety shows significant improvements during treatment with some outcomes indicating continued benefit up to 4 weeks post-treatment. Most treatment-related AEs were mild in nature (83.9%, 256/305 events) including wind (73.9%), headache (58.7%), and stomach pain (31.5%). While no events met criteria for serious or severe intensity, seven participants (7.6%) withdrew owing to AEs. Conclusion: Short-term UK-approved chloral hydrate may provide a potential option for severe adult insomnia only when prior treatments have failed. Trial Registration: NCT06053840 (https://clinicaltrials.gov); ISRCTN10433315 (https://www.isrctn.com/).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.