What is Lemborexant studying for insomnia?

Lemborexant is being studied to see if it can reduce blood markers linked to brain cell damage in adults with insomnia. This research aims to better understand potential neuroprotective effects of the drug. The trial is coordinated by the Woolcock Institute of Medical Research.

Who may be eligible for this insomnia clinical trial?

Adults aged 40 to 65 with a diagnosis of insomnia disorder and a specific severity score may qualify. Both men and women can participate, but certain health conditions and medication uses may exclude some people. Please review eligibility criteria for more details.

Is there any cost to participate in this insomnia clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel and related expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 40Years - 65Years

All Genders

ID06823752

A Dual Orexin Receptor Antagonist to Reduce Biomarkers of Neurodegeneration in Adults With Insomnia Disorder a Randomised Placebo-controlled Cross-over Study

Led by Woolcock Institute of Medical Research · Updated on 2025-10-03

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the potential neuroprotective effects of a dual orexin receptor antagonist DORA called Lemborexant in adults with insomnia. The main goal is to see if this treatment reduces blood biomarkers linked to neurodegeneration, including phosphorylated TAU181, TAU217, amyloid beta 4042 ratio, Neurofilament Light Chain NFL, and Glial Fibrillary Acidic Protein GFAP compared to a placebo. This is a randomized, placebo-controlled crossover study focusing on adults aged 40 to 65 with insomnia disorder. Participants will take 10mg of Lemborexant orally each night for two weeks and a matching placebo nightly for another two weeks, with a 2 to 4 week washout period between treatments. After each treatment phase, participants will visit the research facility for an overnight stay lasting about 18 hours. During this visit, they will undergo various assessments including high-density EEG, functional near-infrared spectroscopy, questionnaires, pupillometry, and blood sample collections. Throughout the study, participants will attend three visits an initial screening and two overnight visits after each treatment period. Blood samples will be collected hourly for four hours following awakening during these visits to measure key biomarkers. Researchers will monitor sleep and brain activity, collect questionnaire data, and evaluate safety. The total involvement includes treatment periods, washout, and overnight assessments, ensuring thorough evaluation of treatment impact on neurodegeneration markers.

CONDITIONS

Brief Title

A Dual Orexin Receptor Antagonist to Reduce Biomarkers of Neurodegeneration in Adults With Insomnia.

Who Can Participate

Age: 40Years - 65Years

All Genders

Eligibility Criteria

You may qualify if you...

Diagnosis of insomnia disorder as defined by the DSM-5 with symptoms at least 3 nights per week for at least 3 months
Insomnia Severity Index score of 15 or higher
Able to provide informed electronic consent
Fluent in English
Adults aged between 40 and 65 years

You will not qualify if you...

Highly dependent on medical care as determined by a medical officer
Untreated moderate to severe sleep apnea (oxygen desaturation index >15) unless effectively treated
Circadian disorders, narcolepsy, severe restless legs syndrome, REM sleep behavior disorder, or uncontrolled psychiatric disorders
History of attempted suicide or current suicidal thoughts
Cognitive decline indicated by a Montreal Cognitive Assessment score of 26 or lower
Recent shift work, jet lag, or travel across more than 2 hours time difference within one week before randomization
Pregnancy or lactation; women advised to use contraception during study
Any condition posing safety concerns or affecting study compliance as judged by investigator
Participation in other investigational studies within 4 weeks prior to enrollment
Use of medications that strongly inhibit or induce CYP3A4 enzymes
Ongoing use of certain medications including antipsychotics, bosentan, efavirenz, etravirine, modafinil, rifampin, carbamazepine, illicit stimulants
Regular use of hypnotics, sedatives, or medications causing sedation within 14 days before trial start
Regular use of psychostimulants within 14 days before trial start
Recent changes in antidepressant treatment within past year
Regular opioid use within 14 days before trial start
Use of THC or CBD products within 14 days prior to trial
Drug or alcohol dependence within past two years (limited alcohol intake allowed during trial)
Allergy to lactose

Research Team

Camilla Hoyos, MPH, PhD

Rhearne Ryan, HScHons, PhD

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