Lemborexant for Insomnia

Overseen By Joyce Ruddley, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Virginia Commonwealth University

Must be taking: Buprenorphine

Must not be taking: Benzodiazepines, Antipsychotics, others

Disqualifiers: Sleep apnea, Insomnia treatment, others

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

Compensation: Varies

Number of Visits: 26

Duration: 8 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how the drug lemborexant, used for insomnia, affects sleep, mood, and behavior in individuals with opioid use disorder who are taking buprenorphine. Researchers seek to determine if lemborexant can improve sleep problems and reduce impulsive actions and mood issues. The study will compare lemborexant's effects to a placebo over an 8-week period. Individuals with opioid use disorder, who are treated with buprenorphine and struggle with chronic insomnia, may be suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating lemborexant's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes people currently taking medications for sleep-related conditions or those that affect the central nervous system, as well as drugs that interact with CYP3A4 enzymes. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that lemborexant is likely to be safe for humans?

Research has shown that lemborexant, a medication for insomnia, has undergone safety testing in several studies. In one study with 1,418 adults, participants reported side effects such as feeling very sleepy (7.65%), having nightmares (1.76%), and experiencing strange dreams (0.59%). Another study found that lemborexant did not affect breathing during sleep, which reassures its safety.

These findings indicate that while lemborexant can cause some side effects, most people tolerate it well. Since lemborexant is already approved for treating insomnia, existing evidence supports its safety in humans. However, consulting healthcare professionals is always important to understand how this medication might work for an individual. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for insomnia?

Lemborexant is unique because it targets the orexin system, which plays a key role in regulating wakefulness. Unlike traditional insomnia treatments like benzodiazepines or Z-drugs that often focus on enhancing GABA activity, lemborexant works by blocking orexin receptors, potentially leading to fewer side effects like daytime drowsiness. Researchers are excited about lemborexant because it offers a novel approach that could improve sleep quality without the dependency risks associated with some current medications.

What evidence suggests that lemborexant might be an effective treatment for insomnia in individuals with opioid use disorder?

Research has shown that lemborexant, which participants in this trial may receive, effectively treats insomnia. Studies indicate that it helps individuals fall back asleep about 21 minutes faster and increases total sleep time by nearly 5%. This means people not only fall back asleep more quickly but also sleep longer overall. Additionally, lemborexant rates highest in several important sleep quality measures compared to other treatments. It is important to note that while a higher dose can slightly improve sleep, it may also increase the chance of next-day drowsiness. Overall, lemborexant has a strong record of improving sleep for those with insomnia. ^{6 7 8 9 10}

Who Is on the Research Team?

Caitlin E Martin, MD

Principal Investigator

Virginia Commonwealth University Institute for Drug and Alcohol Studies

Are You a Good Fit for This Trial?

This trial is for men and women with Opioid Use Disorder who are currently on prescribed buprenorphine. Participants should be interested in how insomnia treatment might affect their sleep, mood, and behavior. Specific eligibility criteria details were not provided.

Inclusion Criteria

Screening urine toxicology negative for non-prescribed substances (except cannabinoids) with a negative breath (or oral fluid) alcohol screen

I have been diagnosed with chronic insomnia.

Meet current DSM-5 criteria for opioid use disorder (OUD) with at least moderate severity

Exclusion Criteria

A positive screen for sleep apnea by specified criteria

I have been diagnosed with a sleep disorder like sleep apnea, narcolepsy, sleepwalking, or sleep paralysis.

I am currently being treated for insomnia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 hours

1 visit (in-person)

Baseline

Baseline assessments including surveys, interviews, and initial measurements

2.5 hours

1 visit (in-person)

Treatment

Participants receive lemborexant or placebo nightly for 8 weeks with regular assessments

8 weeks

23 visits (mostly short, 15-30 minutes)

Post-medication

Final assessments after completion of medication period

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lemborexant

Trial Overview The study tests if Lemborexant improves sleep, reduces impulsive behavior, and betters mood compared to a placebo over an 8-week period. It involves taking the medication nightly and attending multiple short visits with some longer ones for assessments.

How Is the Trial Designed?

Group I: Lemborexant Experimental Treatment 1 Intervention

Lemborexant (trade name Dayvigo), 10mg capsules, administered orally

Group II: Placebo Placebo Group 1 Intervention

Subjects who are randomized to placebo will receive identical capsules to the test product, administered orally.

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10394202/

Comparative efficacy of lemborexant and other insomnia ... CONCLUSIONS: Lemborexant was ranked highest of the treatments studied on 3 out of the 4 objectively measured insomnia efficacy outcomes, with a safety profile ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1389945725004988

Efficacy and safety of lemborexant in patients with insomnia Lemborexant significantly reduced WASO (MD: 20.73 min; 95 % CI: 28.58 to −12.88), improved sleep efficiency (MD: 4.84 %; 95 % CI: 2.69 to 7.00), and reduced ...

3. aafp.org aafp.org/pubs/afp/issues/2021/0215/p241.html

Lemborexant (Dayvigo) for the Treatment of Insomnia Long-term effectiveness and safety of lemborexant in adults with insomnia disorder: 12-month results from SUNRISE-2. Sleep Med. 2019;64(1): ...

4. academic.oup.com academic.oup.com/ijpp/advance-article/doi/10.1093/ijpp/riaf077/8266843?searchresult=1

Is bigger better? Analysis of efficacy and safety of lemborexant ... Lemborexant 10 mg as an initial dose offers minimal improvement in sleep metrics over 5 mg but increases somnolence risk. No evidence supports ...

5. nature.com nature.com/articles/s41398-025-03439-8

Comparative efficacy and safety of daridorexant ... Therefore, any DORAs may be expected to improve overall sleep quality when administered in doses appropriate for each individual with insomnia.

6. mayoclinic.org mayoclinic.org/drugs-supplements/lemborexant-oral-route/description/drg-20487084

Lemborexant (oral route) - Side effects & dosage Lemborexant is used to treat insomnia (sleeping problems). It belongs to the ... Safety and efficacy have not been established. Geriatric. Appropriate ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11315815/

Safety and Efficacy of Lemborexant in Insomnia Patients The incidence of adverse drug reactions (ADRs) was 7.65% for somnolence, 1.76% for nightmares, 0.59% for abnormal dreams, and 0.20% for sleep ...

8. 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 ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1389945721000654

Long-term effectiveness and safety of lemborexant in ... Here we report effectiveness and safety outcomes of lemborexant in subjects with insomnia who received up to twelve months of continuous lemborexant treatment ...

10. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2019/212028s000lbl.pdf

1 This label may not be the latest approved by FDA. For ... The safety of DAYVIGO was evaluated in 1418 adult patients with insomnia disorder (age18 to 88 years) from two controlled efficacy trials (Study 1 and Study 2).