Chloral hydrate improves symptoms of severe insomnia at 2 weeks

Topline results from the open-label RESTORE trial showed that chloral hydrate improved symptoms of severe insomnia at 14 days in patients for whom previous behavioral and pharmaceutical solutions have failed.

According to a press release from Pharmanovia, the study of 100 adult patients reached its primary endpoint: a significant decrease from baseline in Insomnia Severity Index score after 2 weeks of treatment. Results also showed an improvement in Pittsburgh Sleep Quality Index score after 2 weeks, as well as significant improvements in patient-reported quality-of-life metrics, some of which continued to improve up to 4 weeks after treatment.

“We are delighted with the topline results of the RESTORE trial,” Stephen Deacon, chief scientific officer at Pharmanovia, said in the release. “We welcome these findings showing that chloral hydrate is effective not just in short-term treatment, but has longer-term benefits after treatment has stopped at 2 weeks, for patients with severe insomnia which is interfering with normal daily life and where other therapies have failed.”

Participants in the decentralized trial, which was conducted in partnership with Lindus Health, came from primary and secondary care sites and were monitored virtually by secondary care sleep specialists. No serious adverse effects were reported, per the release.

Full data from the study are expected to be released in 2025, according to Pharmanovia.

“The results from the RESTORE trial demonstrate the value and potential of decentralized trial design,” Michael Young, co-founder of Lindus Health, said in the release. “We’re excited to see what’s to come from the full results next year as we look to provide an effective option for people living with severe insomnia.”