Summary
Suvorexant 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trials linking Suvorexant to Insomnia / Sleep Disorders: 2 are currently recruiting; 5 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT03818581). The largest enrolment is 1020 participants (NCT01097629). Registration activity spans 2008 to 2025. The literature layer holds 17 publications for this pair: 5 Cochrane reviews, 4 meta-analyses, 2 systematic reviews, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2022 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: 2 recruiting, 0 active / not yet recruiting, 5 completed, 1 other |
| Linked publications | 17 (5 Cochrane reviews, 5 clinical trial publications, 4 meta-analyses, 2 systematic reviews, 1 randomised controlled trial publication) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT03818581 | Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes 2019 | completed | Phase 4 | 108 |
| NCT03312517 | Study to Compare the Awakening Threshold Effects of Belsomra 10 mg and 20 mg to Placebo in Non-elderly Insomniacs 2018 | completed | Phase 4 | 12 |
| NCT05823844 | Efficacy of Suvorexant on Post-operative Sleep Disturbance 2023 | recruiting | Phase 4 | 92 |
| NCT02684136 | Suvorexant in Insomnia Co-morbid With Fibromyalgia 2016 | terminated | Phase 4 | 10 |
| NCT01097629 | Safety and Efficacy Study of Suvorexant in Participants With Primary Insomnia - Study B (MK-4305-029) 2010 | completed | Phase 3 | 1,020 |
| NCT00792298 | Phase IIB 2-Period Crossover Polysomnography Study in Participants With Primary Insomnia (MK-4305-006) 2008 | completed | Phase 2 | 254 |
| NCT06679062 | Suvorexant for Treatment of AUD and PTSD 2025 | recruiting | Phase 2 | 76 |
| NCT01043926 | Pharmacokinetics of Suvorexant in Participants With Hepatic Insufficiency (MK-4305-017) 2010 | completed | Phase 1 | 16 |
Published literature
- Clinical trial publication Smartphone-Based Real-Time Assessment of Daytime Insomnia Symptoms With Suvorexant: A Randomized Clinical TrialWickwire EM, Zhou J, Chen S et al. · JAMA network open · 2026 · PMID 41490112
- 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
- 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
- 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
- Clinical trial publication Improvement in self-reported, but not actigraphic, sleep measures with suvorexant in people with well-controlled Restless Legs Syndrome and persistent insomniaWinkelman JW, Zackon J, Kilty A · Sleep medicine · 2024 · PMID 39260076
- Clinical trial publication Efficacy and Safety of Transitioning to Lemborexant from Z-drug, Suvorexant, and Ramelteon in Japanese Insomnia Patients: An Open-label, Multicenter StudyOzone M, Hirota S, Ariyoshi Y et al. · Advances in therapy · 2024 · PMID 38460107
- 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
- Meta-analysis Association between the use of orexin receptor antagonists and falls or fractures: A meta-analysisPan G, Ni L, Yan H et al. · Journal of psychiatric research · 2024 · PMID 38944018
- Meta-analysis Residual effects of medications for sleep disorders on driving performance: A systematic review and network meta-analysis of randomized controlled trials: NMA driving and hypnoticsFornaro M, Caiazza C, Rossano F et al. · European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology · 2024 · PMID 38401406
- Meta-analysis Clinical safety and narcolepsy-like symptoms of dual orexin receptor antagonists in patients with insomnia: a systematic review and meta-analysisNa HJ, Jeon N, Staatz CE et al. · Sleep · 2024 · PMID 37950346
- 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
- Cochrane review The Comparative Effectiveness and Safety of Insomnia Drugs: A Systematic Review and Network Meta-Analysis of 153 Randomized TrialsPan B, Ge L, Lai H et al. · Drugs · 2023 · PMID 36947394
- Clinical trial publication Assessment of Suvorexant and Eszopiclone as Alternatives to Benzodiazepines for Treating Insomnia in Patients With Major Depressive DisorderShigetsura Y, Imai S, Endo H et al. · Clinical neuropharmacology · 2022 · PMID 35579484
- Clinical trial publication Evaluation of suvorexant for trauma-related insomniaMellman TA, Birku K, Sandhu I et al. · Sleep · 2022 · PMID 35554590
- Cochrane review Comparative effects of pharmacological interventions for the acute and long-term management of insomnia disorder in adults: a systematic review and network meta-analysisDe Crescenzo F, D'Alò GL, Ostinelli EG et al. · Lancet (London, England) · 2022 · PMID 35843245
- Randomized controlled trial A double-blind, randomized, placebo-controlled trial of suvorexant for the treatment of vasomotor symptom-associated insomnia disorder in midlife womenRahman SA, Nathan MD, Wiley A et al. · Sleep · 2022 · PMID 35022783
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 Suvorexant approved for Insomnia / Sleep Disorders?
Suvorexant 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 Suvorexant in clinical trials for Insomnia / Sleep Disorders?
ClinicalTrials.gov lists 8 registered trials linking Suvorexant to Insomnia / Sleep Disorders: 2 are currently recruiting; 5 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT03818581). The largest enrolment is 1020 participants (NCT01097629). Registration activity spans 2008 to 2025.
What does the evidence show for Suvorexant in Insomnia / Sleep Disorders?
Suvorexant 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.