Chloral Hydrate in the Treatment of Severe Insomnia When Other Treatments Have Failed: Results From a Real-World Evidence Study (RESTORE).

John A Groeger¹, John Luke Twelves², Jan Multmeier², Hannah Swayze², Mushtaque Mastim Snr³, Adrian Williams⁴, Stephen Deacon³

¹Nottingham Trent University, Nottingham, UK.

²Lindus Health, London, UK.

³Pharmanovia, Basildon, UK.

⁴Queen Victoria Hospital NHS Foundation Trust, East Grinstead, UK.

PubMed PMC DOI PDF

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 o…

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