Summary
Temazepam 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 6 registered trials linking Temazepam to Insomnia / Sleep Disorders: 6 have completed. The most advanced is Phase 4 (NCT00465972). The largest enrolment is 44 participants (NCT03928301). Registration activity spans 2005 to 2019. The literature layer holds 12 publications for this pair: 4 Cochrane reviews, 3 meta-analyses and 5 clinical trial publications. Publication years run from 2003 to 2024. 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 | 71.5 (trials 21.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 6 total: 0 recruiting, 0 active / not yet recruiting, 6 completed, 0 other |
| Linked publications | 12 (5 clinical trial publications, 4 Cochrane reviews, 3 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00465972 | The Treatment of Insomnia in Patients With HIV Disease 2007 | completed | Phase 4 | 44 |
| NCT02153788 | Efficacy and Safety of Temazepam in HIV Seropositive Patients With Insomnia 2009 | completed | Phase 4 | 44 |
| NCT00245661 | Effects of Temazepam in Patients With Chronic Pulmonary Obstructive Disease 2005 | completed | Phase 3 | 14 |
| NCT00940550 | Study to Investigate the Effects of Melatonin, Temazepam & Zolpidem on Sleep EEG in Men and Women 2009 | completed | Phase 1 | 16 |
| NCT01519544 | Comparison of Temazepam and Acetazolamide to Treat Difficulty Sleeping at High Altitude 2012 | completed | Not applicable | 34 |
| NCT03928301 | Efficacy of Wholetones® 2Sleep Music on Health and Sleep Behaviors of Healthy Adults With Insomnia Symptoms 2019 | completed | Not applicable | 44 |
Published literature
- Clinical trial publication Masked Taper With Behavioral Intervention for Discontinuation of Benzodiazepine Receptor Agonists: A Randomized Clinical TrialFung CH, Alessi C, Martin JL et al. · JAMA internal medicine · 2024 · PMID 39374004
- Clinical trial publication Temazepam or Melatonin Versus Placebo for the Treatment of Insomnia in Advanced Cancer: A Three-Arm, Double-Blind, Phase III, Multicenter, Randomized Clinical TrialMendis R, Wong A, Frenkel S et al. · Journal of palliative medicine · 2024 · PMID 39304187
- Meta-analysis Comparative efficacy and safety of hypnotics for insomnia in older adults: a systematic review and network meta-analysisChiu HY, Lee HC, Liu JW et al. · Sleep · 2021 · PMID 33249496
- Cochrane review Pharmacological interventions for the treatment of insomnia: quantitative comparison of drug efficacyZheng X, He Y, Yin F et al. · Sleep medicine · 2020 · PMID 32544795
- Clinical trial publication Withdrawal from long-term use of zopiclone, zolpidem and temazepam may improve perceived sleep and quality of life in older adults with primary insomniaLähteenmäki R, Neuvonen PJ, Puustinen J et al. · Basic & clinical pharmacology & toxicology · 2019 · PMID 30295409
- Cochrane review Comparative effectiveness and safety of pharmacological and non-pharmacological interventions for insomnia: an overview of reviewsRios P, Cardoso R, Morra D et al. · Systematic reviews · 2019 · PMID 31730011
- Clinical trial publication Long-term persistence of withdrawal of temazepam, zopiclone, and zolpidem in older adults: a 3-year follow-up studyPuustinen J, Lähteenmäki R, Nurminen J et al. · BMC geriatrics · 2018 · PMID 29907085
- Meta-analysis Pharmacological agents for improving sleep quality at high altitude: a systematic review and meta-analysis of randomized controlled trialsKong F, Liu G, Xu J · Sleep medicine · 2018 · PMID 30121387
- Clinical trial publication Handgrip strength and balance in older adults following withdrawal from long-term use of temazepam, zopiclone or zolpidem as hypnoticsNurminen J, Puustinen J, Lähteenmäki R et al. · BMC geriatrics · 2014 · PMID 25416480
- Cochrane review Insomnia in the elderlyMontgomery P, Lilly J · BMJ clinical evidence · 2007 · PMID 19450355
- Cochrane review Comparative efficacy of newer hypnotic drugs for the short-term management of insomnia: a systematic review and meta-analysisDündar Y, Dodd S, Strobl J et al. · Human psychopharmacology · 2004 · PMID 15252823
- Meta-analysis Toward evidence-based prescribing at end of life: a comparative review of temazepam and zolpidem for the treatment of insomniaBain KT, Weschules DJ, Knowlton CH et al. · The American journal of hospice & palliative care · 2003 · PMID 14529041
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 Temazepam approved for Insomnia / Sleep Disorders?
Temazepam 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 Temazepam in clinical trials for Insomnia / Sleep Disorders?
ClinicalTrials.gov lists 6 registered trials linking Temazepam to Insomnia / Sleep Disorders: 6 have completed. The most advanced is Phase 4 (NCT00465972). The largest enrolment is 44 participants (NCT03928301). Registration activity spans 2005 to 2019.
What does the evidence show for Temazepam in Insomnia / Sleep Disorders?
Temazepam 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.