Summary
Estazolam 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 Estazolam to Insomnia / Sleep Disorders: 1 is currently recruiting; 1 is active or not yet recruiting; 3 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT07306494). It plans or enrolled 1200 participants. Registration activity spans 2006 to 2026. The literature layer holds 11 publications for this pair: 3 Cochrane reviews, 2 meta-analyses, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2008 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 | 75.5 (trials 25.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 1 active / not yet recruiting, 3 completed, 3 other |
| Linked publications | 11 (5 clinical trial publications, 3 Cochrane reviews, 2 meta-analyses, 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00956319 | A Study to Evaluate Efficacy and Safety of Zolpidem Modified Release Formulation in Insomnia Patients 2009 | completed | Phase 4 | 42 |
| NCT07306494 | Compound Ciwujia Granules in the Treatment of Insomnia 2026 | not yet recruiting | Phase 4 | 1,200 |
| NCT03997058 | Observation on the Effect of Auricular Acupoint Pressing on Insomnia and Adverse Events in MHD 2019 | status unknown | Phase 4 | 120 |
| NCT00347295 | Randomised, Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients. 2006 | completed | Phase 3 | 253 |
| NCT06859190 | Efficacy of Auricular Pressure Beans with Electroacupuncture and Estazolam Treating Insomnia Caused by Cancer 2025 | recruiting | Phase 3 | 60 |
| NCT05452577 | Treatment of Chronic Insomnia According to Yin Yang Theory and Its Correlation With Circadian Rhythm 2021 | completed | Not applicable | 187 |
| NCT06212934 | "Chou's Tiaoshen" Acupoints for Short-term Insomnia. 2024 | status unknown | Not applicable | 96 |
| NCT06258226 | A Randomized Controlled Trial of Auricular Acupressure in Treating Estazolam-dependent Insomnia 2024 | status unknown | Not applicable | 108 |
Published literature
- Clinical trial publication [Clinical efficacy of acupuncture combined with estazolam on chronic insomnia]Shen RS, Shi JT, Zhang XY et al. · Zhen ci yan jiu = Acupuncture research · 2026 · PMID 42343684
- Clinical trial publication Suanzaoren decoction improving chronic insomnia with little effects on functional connectivity within the sensorimotor networkYao P, Guo Z, Han Y et al. · Brain research · 2026 · PMID 41297836
- Clinical trial publication Altered cerebral functional activity and its associated genetic profiles underlying chronic insomnia disorder before and after treatmentZhang L, Guo Z, Han Y et al. · The world journal of biological psychiatry : the official journal of the World Federation of Societies of Biological Psychiatry · 2025 · PMID 40384005
- Clinical trial publication [Effects of Tiaoshu Anshen acupuncture on sleep quality and serum neurotransmitter levels in patients with chronic insomnia]Liu L, Yan T, Chen Z et al. · Zhongguo zhen jiu = Chinese acupuncture & moxibustion · 2025 · PMID 39943753
- Cochrane review Efficacy and safety of Chaihu plus Longgu Muli decoction combined with Estazolam in the treatment of insomnia: a meta-analysisLi M, Cai Z, Zhong X et al. · Sleep & breathing = Schlaf & Atmung · 2025 · PMID 40581702
- Clinical trial publication [Clinical effect of the warm acupuncture of Mongolian medicine on insomnia in the elderly and its brain-gut peptide mechanism: a randomized controlled trial]Cao L, Shen M, Yu H et al. · Zhongguo zhen jiu = Chinese acupuncture & moxibustion · 2024 · PMID 38986591
- Randomized controlled trial [Clinical effect of acupuncture based on syndrome differentiation in the treatment of chronic insomnia and its influence on cognitive function]Wu BX, Yang S, Huang R et al. · Zhongguo zhen jiu = Chinese acupuncture & moxibustion · 2023 · PMID 37697875
- Cochrane review Acupuncture for cancer-related insomnia: A systematic review and meta-analysisZhang J, Zhang Z, Huang S et al. · Phytomedicine : international journal of phytotherapy and phytopharmacology · 2022 · PMID 35636168
- Cochrane review Clinical effectiveness of Tui Na for insomnia compared with estazolam: A systematic review and meta-analysis of randomized controlled trialsFeng G, Han M, Li X et al. · Complementary therapies in medicine · 2019 · PMID 31779989
- Meta-analysis Acupuncture for Primary Insomnia: An Updated Systematic Review of Randomized Controlled TrialsCao HJ, Yu ML, Wang LQ et al. · Journal of alternative and complementary medicine (New York, N.Y.) · 2019 · PMID 31013432
- Meta-analysis Auricular acupuncture for insomnia: a systematic reviewLee MS, Shin BC, Suen LK et al. · International journal of clinical practice · 2008 · PMID 18754807
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 Estazolam approved for Insomnia / Sleep Disorders?
Estazolam 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 Estazolam in clinical trials for Insomnia / Sleep Disorders?
ClinicalTrials.gov lists 8 registered trials linking Estazolam to Insomnia / Sleep Disorders: 1 is currently recruiting; 1 is active or not yet recruiting; 3 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT07306494). It plans or enrolled 1200 participants. Registration activity spans 2006 to 2026.
What does the evidence show for Estazolam in Insomnia / Sleep Disorders?
Estazolam 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.