Lemborexant in Delayed Sleep Phase Syndrome

Summary

The purpose of the study is to evaluate whether Lemborexant is more effective than placebo in shortening sleep onset latency in patients with delayed sleep phase syndrome (both type 1 and type 2). This will be tracked using sleep logs as well as actigraphy. In this 2-year study, the investigators will examine if Lemborexant administered 5-10 mg nightly taken at desired bedtime (at least 2 hours prior to self-reported sleep onset habitual time) can improve the symptoms of Delayed Sleep Phase Syndrome.

Timeline

Start

2023-03-13

Primary completion

2027-05-31

Completion

2027-05-31

Publications

• Background Duffy JF, Dijk DJ, Hall EF, Czeisler CA; New Collective Author. Relationship of endogenous circadian melatonin and temperature rhythms to self-reported preference for morning or evening activity in young and older people. J Investig Med. 1999 Mar;47(3):141-50.
• Background Micic G, Richardson C, Cain N, Reynolds C, Bartel K, Maddock B, Gradisar M. Readiness to change and commitment as predictors of therapy compliance in adolescents with Delayed Sleep-Wake Phase Disorder. Sleep Med. 2019 Mar;55:48-55. doi: 10.1016/j.sleep.2018.12.002. Epub 2018 Dec 14.
• Background Zeitzer JM, Joyce DS, McBean A, Quevedo YL, Hernandez B, Holty JE. Effect of Suvorexant vs Placebo on Total Daytime Sleep Hours in Shift Workers: A Randomized Clinical Trial. JAMA Netw Open. 2020 Jun 1;3(6):e206614. doi: 10.1001/jamanetworkopen.2020.6614.
• Background Zeitzer JM, Buckmaster CL, Lyons DM, Mignot E. Increasing length of wakefulness and modulation of hypocretin-1 in the wake-consolidated squirrel monkey. Am J Physiol Regul Integr Comp Physiol. 2007 Oct;293(4):R1736-42. doi: 10.1152/ajpregu.00460.2007. Epub 2007 Aug 8.
• Background Zhang S, Zeitzer JM, Yoshida Y, Wisor JP, Nishino S, Edgar DM, Mignot E. Lesions of the suprachiasmatic nucleus eliminate the daily rhythm of hypocretin-1 release. Sleep. 2004 Jun 15;27(4):619-27. doi: 10.1093/sleep/27.4.619.

Drugs

Indications