Summary
Lemborexant has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Insomnia / Sleep Disorders would be drug repurposing rather than first-in-human development. This does not mean it is approved for Insomnia / Sleep Disorders. ClinicalTrials.gov lists 8 registered trials linking Lemborexant to Insomnia / Sleep Disorders: 3 are currently recruiting; 5 have completed. The most advanced is Phase 4 (NCT04742699). The largest enrolment is 1006 participants (NCT02783729). Registration activity spans 2011 to 2025. The literature layer holds 14 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 2 systematic reviews and 5 clinical trial publications. Publication years run from 2023 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Insomnia ranks 317 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Acute insomnia (<3 months): 50-60% resolve spontaneously; chronic insomnia: only 20-25% spontaneous remission at 1 year; persistent insomnia in 50-75% without treatment.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 80.0 (trials 30.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 3 recruiting, 0 active / not yet recruiting, 5 completed, 0 other |
| Linked publications | 14 (5 Cochrane reviews, 5 clinical trial publications, 2 meta-analyses, 2 systematic reviews) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT04742699 | An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Transitioning to Lemborexant in Japanese Subjects With Insomnia 2021 | completed | Phase 4 | 97 |
| NCT02783729 | Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1) 2016 | completed | Phase 3 | 1,006 |
| NCT06496282 | Lemborexant on Improving Sleep Quality Among Hospital Rotating Shift Workers 2024 | recruiting | Phase 3 | 50 |
| NCT05594589 | A Study to Assess the Pharmacodynamics of Lemborexant in Korean Participants With Insomnia Disorder 2022 | completed | Phase 2 | 65 |
| NCT06981195 | Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects 2025 | recruiting | Phase 2 | 100 |
| NCT02350309 | Study to Evaluate the Effect of 2 Dosage Strengths of Lemborexant (E2006) on a Multiple Sleep Latency Test in Participants With Insomnia Disorder 2014 | completed | Phase 1 | 69 |
| NCT01463098 | A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 2011 | completed | Phase 1 | 122 |
| NCT05618002 | Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients 2022 | recruiting | Not applicable | 150 |
Published literature
- Clinical trial publication A phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial of lemborexant in adults with insomnia disorderMi WF, Wen D, Xu L et al. · Sleep medicine · 2026 · PMID 41442783
- Clinical trial publication Effect of lemborexant on sleep parameters and architecture in adult and elderly participants with mild-to-severe obstructive sleep apneaKhullar A, Boulos MI, Mak MSB et al. · Sleep medicine · 2025 · PMID 40848323
- Clinical trial publication Effect of lemborexant on sleep architecture in participants with insomnia disorder and mild obstructive sleep apneaKushida CA, Zammit GK, Cheng JY et al. · Sleep medicine · 2025 · PMID 39879708
- Clinical trial publication Effect of Lemborexant on Daytime Functioning in Adults With Insomnia: Patient-Reported Outcomes From a Phase 3 Clinical TrialChepke C, Cote KA, Pinner K et al. · The primary care companion for CNS disorders · 2025 · PMID 39823487
- Clinical trial publication Efficacy and safety of lemborexant in subjects with insomnia disorder receiving medications for depression or anxiety symptomsKrystal A, Blier P, Culpepper L et al. · Neuropsychopharmacology reports · 2025 · PMID 39632341
- Cochrane review Efficacy and safety of insomnia pharmacotherapies: Convergent evidence from Bayesian network meta-regression and FAERS-based disproportionality analysisLiu H, Wang Y, Li M et al. · Sleep medicine · 2025 · PMID 41101148
- Cochrane review Efficacy and safety of lemborexant in patients with insomnia: a systematic review and meta-analysisKhan A, Rath S, Khan H et al. · Sleep medicine · 2025 · PMID 41005182
- Cochrane review Efficacy and safety of lemborexant vs placebo in treating adults with insomnia disorder: a systematic review and meta-analysis of 1976 patientsAlsaied MA, Elettreby AM, Serag I et al. · Naunyn-Schmiedeberg's archives of pharmacology · 2025 · PMID 40244447
- Meta-analysis Comparative efficacy and safety of daridorexant, lemborexant, and suvorexant for insomnia: a systematic review and network meta-analysisKishi T, Ikuta T, Citrome L et al. · Translational psychiatry · 2025 · PMID 40555730
- Meta-analysis Comparison of efficacy and safety of dual orexin receptor antagonists lemborexant and daridorexant for the treatment of insomnia: a systematic review and meta-analysisTang M, Shen Z, Yu P et al. · Psychopharmacology · 2025 · PMID 40133470
- Systematic review Efficacy and safety profiles of FDA-approved dual orexin receptor antagonists in depression: A systematic review of pre-clinical and clinical studiesVasudeva S, Wong S, Le GH et al. · Journal of psychiatric research · 2025 · PMID 41109037
- Systematic review The putative effects of orexin receptor antagonists on pain and sleep in humans: A systematic reviewHerrero Babiloni A, Sangalli L, Puertas-Cuesta FJ et al. · Sleep medicine · 2025 · PMID 40532597
- Cochrane review Orexin receptor antagonists in the treatment of insomnia associated with psychiatric disorders: a systematic reviewKishi T, Koebis M, Sugawara M et al. · Translational psychiatry · 2024 · PMID 39277609
- Cochrane review Dual orexin receptor antagonists for the treatment of insomnia: systematic review and network meta-analysisRocha RB, Bomtempo FF, Nager GB et al. · Arquivos de neuro-psiquiatria · 2023 · PMID 37257468
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Lemborexant approved for Insomnia / Sleep Disorders?
Lemborexant has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Insomnia / Sleep Disorders would be drug repurposing rather than first-in-human development. This does not mean it is approved for Insomnia / Sleep Disorders. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Lemborexant in clinical trials for Insomnia / Sleep Disorders?
ClinicalTrials.gov lists 8 registered trials linking Lemborexant to Insomnia / Sleep Disorders: 3 are currently recruiting; 5 have completed. The most advanced is Phase 4 (NCT04742699). The largest enrolment is 1006 participants (NCT02783729). Registration activity spans 2011 to 2025.
What does the evidence show for Lemborexant in Insomnia / Sleep Disorders?
Lemborexant has both completed registered trials and synthesis-level publications linked to Insomnia / Sleep Disorders. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.