Summary
Zolpidem Tartrate 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linking Zolpidem Tartrate to Insomnia / Sleep Disorders: 1 is currently recruiting; 6 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT07542756). It plans or enrolled 1200 participants. Registration activity spans 2001 to 2026. The literature layer holds 7 publications for this pair: 2 meta-analyses and 5 clinical trial publications. Publication years run from 1997 to 2025. 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 | 67.0 (trials 29.0, literature 18.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 0 active / not yet recruiting, 6 completed, 1 other |
| Linked publications | 7 (5 clinical trial publications, 2 meta-analyses) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00156533 | Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing 2005 | completed | Phase 4 | 20 |
| NCT00530556 | Insomnia and Daytime Function in Osteoarthritis 2003 | completed | Phase 4 | 170 |
| NCT07542756 | A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia 2026 | recruiting | Phase 4 | 1,200 |
| NCT05456152 | Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia 2024 | status unknown | Phase 3 | 358 |
| NCT00044629 | Combined Behavioral/Pharmacological Therapy for Insomnia 2001 | completed | Phase 2 | 162 |
| NCT02839200 | Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder 2016 | completed | Phase 2 | 360 |
| NCT00662155 | The Role of Partial Reinforcement in the Long Term Management of Insomnia 2006 | completed | Not applicable | 129 |
| NCT01685073 | The Role of Sleep in the Treatment of Cannabis Use Disorders 2012 | completed | PHASE2, PHASE3 | 127 |
Published literature
- 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 Efficacy and safety of insomnia treatment with lemborexant in older adults: analyses from three clinical trialsGotfried MH, Auerbach SH, Dang-Vu TT et al. · Drugs & aging · 2024 · PMID 39120786
- Clinical trial publication Comparison of the treatment effectiveness between lemborexant and zolpidem tartrate extended-release for insomnia disorder subtypes defined based on polysomnographic findingsInoue Y, Nishida M, Kubota N et al. · Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2023 · PMID 36472134
- Clinical trial publication Comparison of the effect of lemborexant with placebo and zolpidem tartrate extended release on sleep architecture in older adults with insomnia disorderMoline M, Zammit G, Cheng JY et al. · Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2021 · PMID 33590823
- Clinical trial publication Safety of lemborexant versus placebo and zolpidem: effects on auditory awakening threshold, postural stability, and cognitive performance in healthy older participants in the middle of the night and upon morning awakeningMurphy P, Kumar D, Zammit G et al. · Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2020 · PMID 32022664
- Meta-analysis Lemborexant vs suvorexant for insomnia: A systematic review and network meta-analysisKishi T, Nomura I, Matsuda Y et al. · Journal of psychiatric research · 2020 · PMID 32531478
- Meta-analysis Benzodiazepines and zolpidem for chronic insomnia: a meta-analysis of treatment efficacyNowell PD, Mazumdar S, Buysse DJ et al. · JAMA · 1997 · PMID 9417012
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 Zolpidem Tartrate approved for Insomnia / Sleep Disorders?
Zolpidem Tartrate 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 Zolpidem Tartrate in clinical trials for Insomnia / Sleep Disorders?
ClinicalTrials.gov lists 8 registered trials linking Zolpidem Tartrate to Insomnia / Sleep Disorders: 1 is currently recruiting; 6 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT07542756). It plans or enrolled 1200 participants. Registration activity spans 2001 to 2026.
What does the evidence show for Zolpidem Tartrate in Insomnia / Sleep Disorders?
Zolpidem Tartrate 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.