Efficacy of Suvorexant in Patients With Effectively Treated Restless Legs Syndrome and Persistent Chronic Insomnia

Summary

The investigators aim to determine the effect of suvorexant on actigraphically-derived total sleep time in patients with effectively treated restless legs syndrome with persistent insomnia in a two-arm, double-blind, randomized placebo-controlled crossover 2.5-month trial.

Timeline

Start

2021-08-12

Primary completion

2023-10-20

Completion

2023-10-20

Outcome

Missed primary endpoint

paper There were no significant improvements in actigraphically-derived TST (p = 0.58) PMID 39260076 ↗

Publications

• Winkelman JW, Zackon J, Kilty A. Improvement in self-reported, but not actigraphic, sleep measures with suvorexant in people with well-controlled Restless Legs Syndrome and persistent insomnia. Sleep Med. 2024 Dec;124:30-37. doi: 10.1016/j.sleep.2024.09.005. Epub 2024 Sep 8.

Drugs

Indications