Recruiting

Lemborexant

Sponsor:

UCLA

Code:

NCT06874855

Conditions

Delayed Sleep Phase Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Lemborexant

Placebo

Study Details

Brief 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.

Conditions

Delayed Sleep Phase Syndrome

Study ID

NCT06874855

Start date

Mar 13, 2023

Status verified date

Jun, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

\- Participants will be required to be 18 years of age or older and have delayed sleep phase syndrome (DSPS). Questionnaires will be used to identify potential confounders and to confirm a potential diagnosis of DSPS based on ICSD3 criteria: a) Sleep is delayed by two hours or more beyond what is considered an acceptable or conventional bedtime for the subject (their desired bedtime). b) Subjects not able to fall asleep if trying to sleep before the later bedtime; c) This is interfering with their wishes/having a 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, or any medical disorder/therapy that could interfere with the trial
  • 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.
  • Pregnancy (verified by urine pregnancy test on visits 1, 2, and 3) or plan to become pregnant 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 screening phase.
  • Transmeridian travel across more than 2 time zones during this trial (including the screening phase).
  • Having a positive drug test or being unwilling to refrain from using illegal drugs or marijuana during this trial.
  • Any clinically abnormal symptom or organ impairment found by medical history at Screening or Baseline and physical examinations, vital signs, or laboratory test results that require medical treatment.
  • Impaired liver function (values for enzymes aspartate transaminase (AST) and alanine transaminase (ALT) > 1.5 times the Upper Limit of Normal).
  • Known to be human immunodeficiency virus positive.

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Patients receive placebo to match Lemborexant for 14 days

active comparator: Lemborexant

Patients receive Lemborexant 5mg for 7 days and may be dose adjusted to 10mg. Patients continue to take Lemborexant 5mg or 10mg for an additional 7 days

Interventions

Lemborexant

Lemborexant tablet administered orally once daily

Placebo

Placebo to match Lemborexant tablet administered orally once daily

Primary outcome measure

  • Change in actigraphy sleep latency onset [ Time Frame: From 2 weeks prior to randomization to 4 weeks post randomization ]

Central Contacts and Locations

Central contacts

Andrew D Krystal, MD, MS

415-476-7702andrew.krystal@ucsf.edu

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94107

Contacts

More Information

Sponsor

University of California, San Francisco

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Keywords

  • Delayed Sleep Phase Syndrome
  • Syndrome
  • Lemborexant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-06-05.