An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients with Severe Insomnia

Summary

The primary aim of this Real-World Evidence trial is to establish whether short-term (2 weeks) treatment of Chloral Hydrate is effective in patients with severe insomnia which is interfering with normal daily life, and where other behavioural and pharmacologic therapies have failed in a real world setting.

Timeline

Start

2023-09-01

Primary completion

2024-04-24

Completion

2024-05-07

Outcome

Met primary endpoint

release “The topline readout found that chloral hydrate significantly improved insomnia symptoms in adults with severe insomnia.” pharmanovia.com ↗

release “The primary efficacy endpoint, change in Insomnia Severity Index (ISI) score from baseline after 2 weeks of treatment, decreased significantly after 14 days of treatment” pharmanovia.com ↗

Publications

• Groeger JA, Twelves JL, Multmeier J, Swayze H, Mastim Snr M, Williams A, Deacon S. Chloral Hydrate in the Treatment of Severe Insomnia When Other Treatments Have Failed: Results From a Real-World Evidence Study (RESTORE). Nat Sci Sleep. 2026 May 19;18:587588. doi: 10.2147/NSS.S587588. eCollection 2026.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Chloral Hydrate	Small molecule	430 mg	Oral
Subject	Chloral Hydrate	Small molecule	860 mg	Oral

Indications