Lemborexant for Night Owl Syndrome

(Eisai DSPS Trial)

Overseen By Andrew D Krystal, MD, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

Must not be taking: Insomnia therapies, Stimulants, CYP3A drugs

Disqualifiers: Depression, Anxiety, Substance use, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Lemborexant can help people with Delayed Sleep Phase Syndrome (DSPS) fall asleep faster. DSPS occurs when a person's sleep is delayed by two hours or more, making it difficult to fall asleep and causing social or work-related issues. Participants will take either Lemborexant (a sleep aid) or a placebo for a short period to assess improvements in sleep onset. Ideal candidates are adults who struggle to fall asleep at a conventional bedtime, affecting their daily life. As a Phase 4 trial, Lemborexant is already FDA-approved and proven effective, and this research seeks to understand how it benefits more patients.

Will I have to stop taking my current medications?

You can continue taking your current medications, but the dosages must stay the same during the study. If you're on medications that affect sleep, you may need to stop them before joining the trial.

What is the safety track record for Lemborexant?

Research has shown that Lemborexant, a treatment for sleep disorders, is generally safe but can cause some side effects. People taking Lemborexant might experience more treatment-emergent adverse events (TEAEs) compared to those not on the medication. These side effects were reported more often in those taking Lemborexant.

However, Lemborexant has been studied for other sleep issues like insomnia and is often well-tolerated over longer periods. In one study where participants took Lemborexant for up to a year, it proved effective and safe. Additionally, no differences in breathing-related issues, measured by the apnea-hypopnea index, were observed in those taking the 10 mg dose, indicating good safety.

Overall, while Lemborexant is associated with some side effects, it has a history of being generally safe for sleep disorders. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for Night Owl Syndrome focus on behavioral changes and melatonin supplements to adjust sleep patterns. But Lemborexant works differently, as it targets the brain's orexin receptors to promote sleep. Unlike traditional options that may take longer to show results, Lemborexant has the potential to help individuals fall asleep faster and maintain sleep more effectively. Researchers are excited about Lemborexant because it offers a new mechanism of action that could provide quicker and more reliable relief for those struggling with this condition.

What is the effectiveness track record for Lemborexant in treating Delayed Sleep Phase Syndrome?

Studies have shown that Lemborexant helps people with insomnia fall asleep faster. Research indicates it significantly reduces the time needed to fall asleep. In another study, patients reported better sleep, less daytime sleepiness, and improved mood after three months of treatment. These findings suggest that Lemborexant could benefit those with delayed sleep phase syndrome, also known as Night Owl Syndrome. In this trial, participants will receive either Lemborexant or a placebo. Existing research well supports the treatment's ability to help people fall asleep more quickly and improve overall sleep patterns. ^{2 6 7 8 9}

Who Is on the Research Team?

Andrew D Krystal, MD, MS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals with Delayed Sleep Phase Syndrome, often called 'Night owl syndrome', where they have trouble falling asleep at conventional times. Participants should be willing to take medication nightly and maintain sleep logs.

Inclusion Criteria

Participants must be willing and able to comply with all aspects of the protocol

I am 18 or older with delayed sleep phase syndrome.

Questionnaires will be used to confirm a potential diagnosis of DSPS based on ICSD3 criteria

Exclusion Criteria

Shift workers or subjects working unusual hours

Any risk of suicide within 6 months of screening period or throughout the trial

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lemborexant 5mg for 7 days, with possible dose adjustment to 10mg, or placebo for 14 days

2 weeks

Follow-up

Participants are monitored for changes in sleep onset latency, sleep regularity, and other sleep parameters using sleep diaries and actigraphy

4 weeks

Long-term monitoring

Participants continue to be monitored for long-term effects of treatment over the 2-year study period

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Lemborexant

Trial Overview

The study tests if Lemborexant helps people with Delayed Sleep Phase Syndrome fall asleep faster compared to a placebo. It's a 2-year study where participants take the drug or placebo at their desired bedtime, which is earlier than usual.

How Is the Trial Designed?

Group I: Lemborexant Active Control 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

Patients receive placebo to match Lemborexant for 14 days

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Eisai Co., Ltd.

Industry Sponsor

Trials

182

Recruited

660,000+

Lynn Kramer

Eisai Co., Ltd.

Chief Medical Officer since 2019

MD from the University of Tokyo

Haruo Naito

Eisai Co., Ltd.

Chief Executive Officer since 1988

Bachelor's degree in Economics from Keio University

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05463861

Lemborexant in Delayed Sleep Phase Syndrome

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 ...

2.

clinicaltrials.ucsf.edu

clinicaltrials.ucsf.edu/trial/NCT06874855

Lemborexant in Delayed Sleep Phase Syndrome

The purpose of the study is to evaluate whether Lemborexant is more effective than placebo in shortening sleep onset latency in patients ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12511177/

Efficacy and safety of lemborexant vs placebo in treating ...

Meta-analysis results revealed that lemborexant could significantly decrease the sleep onset latency in patients with insomnia compared to ...

4.

media-us.eisai.com

media-us.eisai.com/2019-09-27-Three-New-Analyses-of-Data-Expand-Understanding-of-the-Potential-Role-for-Investigational-Agent-Lemborexant-in-Insomnia-and-Irregular-Sleep-Wake-Rhythm-Disorder

Three New Analyses of Data Expand Understanding of the ...

Treatment with lemborexant 10 mg resulted in mean increases from baseline of 1.3 at six months and 1.6 at 12 months. Treatment with placebo ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10960545/

Assessing the Real-World, Long-Term Impact of ...

Sleep disturbance, excessive sleepiness, and depressive symptoms improved after three months of lemborexant treatment. Conclusion. Furthermore, ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41005182/

Efficacy and safety of lemborexant in patients with insomnia

Lemborexant was associated with a higher risk of treatment-related TEAEs (RR: 1.82; 95 % CI: 1.41 to 2.34) but showed no significant difference ...

7.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06874855/lemborexant-in-delayed-sleep-phase-syndrome

Lemborexant in Delayed Sleep Phase Syndrome

The purpose of the study is to evaluate whether Lemborexant is more effective than placebo in shortening sleep onset latency in patients ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33636648/

results from a phase 3 randomized clinical trial

We report effectiveness and safety outcomes in subjects with insomnia who received up to twelve months of continuous lemborexant treatment in Study E2006-G000- ...

9.

media-us.eisai.com

media-us.eisai.com/2019-06-11-Lemborexant-Respiratory-Safety-Data-Presented-at-SLEEP-2019

Lemborexant Respiratory Safety Data Presented at SLEEP 2019

The study met its primary endpoint, finding there was no difference in least squares mean (LSM) apnea-hypopnea index (AHI) for lemborexant 10 mg ...