Summary
Eszopiclone 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 Eszopiclone to Insomnia / Sleep Disorders: 1 is currently recruiting; 1 is active or not yet recruiting; 6 have completed. The most advanced is Phase 4 (NCT07018557). The largest enrolment is 791 participants (NCT01710631). Registration activity spans 2001 to 2027. The literature layer holds 14 publications for this pair: 5 Cochrane reviews, 1 meta-analysis, 2 systematic reviews, 1 randomised controlled trial publication 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: 1 recruiting, 1 active / not yet recruiting, 6 completed, 0 other |
| Linked publications | 14 (5 Cochrane reviews, 5 clinical trial publications, 2 systematic reviews, 1 meta-analysis, 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00247624 | Improving Sleep and Psychological Functioning in People With Depression and Insomnia 2005 | completed | Phase 4 | 60 |
| NCT01605253 | Eszopiclone for the Treatment of Posttraumatic Stress Disorder 2012 | completed | Phase 4 | 81 |
| NCT07018557 | Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN) 2025 | recruiting | Phase 4 | 150 |
| NCT00367965 | Study of Eszopiclone Compared to Placebo on Daytime Function in Subjects With Insomnia Related to Rheumatoid Arthritis 2004 | completed | Phase 3 | 153 |
| NCT01710631 | Twelve Month Study of the Safety of Eszopiclone in Adult Subjects With Insomnia 2001 | completed | Phase 3 | 791 |
| NCT00856973 | Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia 2009 | completed | Phase 3 | 486 |
| NCT06452953 | Modified Suanzaoren Decoction Versus Eszopiclone for the Treatment of Chronic Insomnia Disorder 2020 | completed | Not applicable | 85 |
| NCT04980703 | Grain Moxibustion Treatment on Insomnia: a Randomized Controlled Trial 2027 | not yet recruiting | Not applicable | 102 |
Published literature
- Cochrane review Comparative efficacy of positive airway pressure-based combination therapy in comorbid insomnia and sleep apnea: A systematic review and network meta-analysisZhang Y, Wang J, Zhang J et al. · Sleep medicine reviews · 2026 · PMID 42107468
- Cochrane review Efficacy of auriculotherapies for primary insomnia: A systematic review and network meta-analysisLuo Z, Shen J, Chen X et al. · Medicine · 2026 · PMID 42071829
- Systematic review Evidence-based pharmacological interventions for insomnia: a systematic review on the effects of eszopiclone on insomnia comorbid with mental disturbancesPalagini L, Dell'Osso BM, Ferini Strambi L et al. · The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry · 2026 · PMID 41840848
- Clinical trial publication [Tiaowei Jiannao acupuncture for post-ischemic stroke insomnia: a randomized controlled trial]Zhang R, Chen X, Wang M et al. · Zhongguo zhen jiu = Chinese acupuncture & moxibustion · 2025 · PMID 41074514
- Clinical trial publication A Mechanistic study assessing difficulty discontinuing chronic hypnotic useRoehrs T, Koshorek G, Sibai M et al. · Psychopharmacology · 2025 · PMID 40342163
- Clinical trial publication Cognitive Behavioral Therapy Alone or in Combination with Eszopiclone in Comorbid Insomnia and Obstructive Sleep Apnea in Veterans with Posttraumatic Stress Disorder: A Randomized TrialEl-Solh AA, Lawson Y, Martinson A et al. · The Psychiatric quarterly · 2025 · PMID 40202618
- 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 Comparative efficacy and safety of different pharmacological interventions for the treatment of depression associated with insomnia in the elderly population: a systematic review and network meta-analysisWang J, Bai L, Bao Y et al. · Psychogeriatrics : the official journal of the Japanese Psychogeriatric Society · 2025 · PMID 40301121
- Meta-analysis Efficacy and Acceptability of Licensed and Off-Label Pharmacological Interventions for Insomnia in Patients With Severe Mental Illness: A Systematic Review and Meta-Analysis of Randomised TrialsFuglsang NFB, Madsen NM, Jacobsen SL et al. · Acta psychiatrica Scandinavica · 2025 · PMID 40898589
- Systematic review Z-drug abuse and dependence: clinical guideline of the Brazilian Academy of Neurology for diagnosis and managementStelzer FG, Bacelar A, Éckeli AL et al. · Arquivos de neuro-psiquiatria · 2025 · PMID 41187937
- 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
- Clinical trial publication Efficacy of Zhumian Tang formula granules combined with eszopiclone for the treatment of poor sleep quality: a multi-center, randomized controlled, superiority trialYichen W, Shiyi WU, Zhengyan W et al. · Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan · 2024 · PMID 38213251
- Cochrane review Efficacy and safety of eszopiclone combined with drug therapy in the treatment of insomnia after stroke: A network meta-analysis and systematic reviewLi RY, Zhu DL, Chen KY · PloS one · 2024 · PMID 38315683
- Randomized controlled trial Improved Sleep Affects Epigastric Pain in Functional Dyspepsia by Reducing the Levels of Inflammatory MediatorsDu H, Lin R, Xiao S et al. · Digestive diseases (Basel, Switzerland) · 2023 · PMID 37607491
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 Eszopiclone approved for Insomnia / Sleep Disorders?
Eszopiclone 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 Eszopiclone in clinical trials for Insomnia / Sleep Disorders?
ClinicalTrials.gov lists 8 registered trials linking Eszopiclone to Insomnia / Sleep Disorders: 1 is currently recruiting; 1 is active or not yet recruiting; 6 have completed. The most advanced is Phase 4 (NCT07018557). The largest enrolment is 791 participants (NCT01710631). Registration activity spans 2001 to 2027.
What does the evidence show for Eszopiclone in Insomnia / Sleep Disorders?
Eszopiclone 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.