Stanford University
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, we 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.
Delayed sleep phase syndrome (DSPS) is a disorder in which a person's sleep is delayed by two hours or more beyond what is considered an acceptable or conventional bedtime. The delayed sleep then causes difficulty in being able to wake up at the desired time. In DSPS, bedtime is shifted later than the general population such that individuals have difficulty getting enough sleep to meet their sleep needs before they have to get up for their daytime obligations (work, school, childcare, etc.). As a result, patients experience daytime impairment, including daytime sleepiness and cognitive impair…
Inclusion Criteria: 1. 18 years of age or older. 2. Diagnosed with delayed sleep phase syndrome (DSPS) meaning that: 1. Sleep is delayed by two hours or more beyond what is considered an acceptable or conventional bedtime for the subject (their desired bedtime). 2. Subjects not able to fall asleep if trying to sleep before the later bedtime; 3. This is interfering with their wishes/having social impact. 3. Concomitant medications will be allowed, though dosages will be required to remain fixed throughout participation in the study. 4. The participant also needs to be willing and abl…
Lemborexant tablet administered orally once daily.
Placebo to match Lemborexant tablet administered orally once daily.
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