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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 18 years of age or older.
✓. Diagnosed with delayed sleep phase syndrome (DSPS) meaning that:
✓. Sleep is delayed by two hours or more beyond what is considered an acceptable or conventional bedtime for the subject (their desired bedtime).
✓. Subjects not able to fall asleep if trying to sleep before the later bedtime;
✓. This is interfering with their wishes/having social impact.
✓. Concomitant medications will be allowed, though dosages will be required to remain fixed throughout participation in the study.
✓. The participant also needs to be willing and able to comply with all aspects of the protocol.
Exclusion criteria
✕. Clinically significant depression (PHQ-9 score of 10 or more), anxiety disorder (GAD-7 score of 10 or more), substance use disorder, any other sleep disorder (assessed by the Alliance Sleep Questionnaire- ASQ), or any medical disorder/therapy that could interfere with the trial (this will be verified through interview and analysis of the ASQ).
✕. Use of medications with significant effects on sleep-wake function (insomnia therapies, stimulants)- unless they are discontinued at least 5 half-lives prior to study participation. Non-sedative antidepressants or SSRI will be allowed if at a stable dose in the absence of concomitant severe depression or severe anxiety.
✕. Use of CYP3A inhibitors and CYP3A inducers, at least 1 week (or five half-lives, whichever is longer) prior to the first day of the baseline phase.
What they're measuring
1
Change in actigraphy sleep latency onset
Timeframe: From 2 weeks prior to randomization to 4 weeks post randomization