Lemborexant in Delayed Sleep Phase Syndrome

Inclusion Criteria:

• Participants will be required to be 18 years of age or older and have delayed sleepphase syndrome (DSPS). Questionnaires will be used to identify potential confoundersand to confirm a potential diagnosis of DSPS based on ICSD3 criteria: a) Sleep isdelayed by two hours or more beyond what is considered an acceptable or conventionalbedtime for the subject (their desired bedtime). b) Subjects not able to fall asleepif trying to sleep before the later bedtime; c) This is interfering with theirwishes/having a social impact. Concomitant medications will be allowed, thoughdosages will be required to remain fixed throughout participation in the study. Theparticipant also needs to be willing and able to comply with all aspects of theprotocol.

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, orany medical disorder/therapy that could interfere with the trial

• Use of medications with significant effects on sleep-wake function (insomniatherapies, stimulants)- unless they are discontinued at least 5 half-lives prior tostudy participation. Non-sedative antidepressants or SSRI will be allowed if at astable 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.

• Pregnancy (verified by urine pregnancy test on visits 1, 2, and 3) or plan to becomepregnant in the next 3 months or currently breastfeeding.

• Shift workers or subjects working unusual hours.

• Transmeridian travel across more than 3 time zones 4 weeks prior to the screeningphase.

• Transmeridian travel across more than 2 time zones during this trial (including thescreening phase).

• Having a positive drug test or being unwilling to refrain from using illegal drugsor marijuana during this trial.

• Any clinically abnormal symptom or organ impairment found by medical history atScreening or Baseline and physical examinations, vital signs, or laboratory testresults that require medical treatment.

• Impaired liver function (values for enzymes aspartate transaminase (AST) and alaninetransaminase (ALT) > 1.5 times the Upper Limit of Normal).

• Known to be human immunodeficiency virus positive.