Summary
Zaleplon 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 7 registered trials linking Zaleplon to Insomnia / Sleep Disorders: 1 is active or not yet recruiting; 6 have completed. The most advanced is Phase 2 (NCT01277107). The largest enrolment is 444 participants (NCT06640023). Registration activity spans 2004 to 2024. The literature layer holds 13 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 1 systematic review and 5 clinical trial publications. Publication years run from 2009 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 | 71.0 (trials 21.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 7 total: 0 recruiting, 1 active / not yet recruiting, 6 completed, 0 other |
| Linked publications | 13 (5 Cochrane reviews, 5 clinical trial publications, 2 meta-analyses, 1 systematic review) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00878553 | Study of Sleep-maintenance Activity of 3 Doses of SKP-1041 2010 | completed | Phase 2 | 67 |
| NCT01277107 | A Polysomnographic Study to Compare the Efficacy of Gastric Retentive Zaleplon Accordion Pill to Placebo in Subjects With Insomnia 2011 | completed | Phase 2 | 83 |
| NCT03489304 | Zaleplon in HIV Patients With Depression 2014 | completed | Phase 2 | 20 |
| NCT06640023 | The Study in Outpatient Medicine Using Nudges to Improve Sleep 2024 | active, not recruiting | Not applicable | 444 |
| NCT03928301 | Efficacy of Wholetones® 2Sleep Music on Health and Sleep Behaviors of Healthy Adults With Insomnia Symptoms 2019 | completed | Not applicable | 44 |
| NCT00694187 | Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions 2004 | completed | Not applicable | 39 |
| NCT00694317 | Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions 2004 | completed | Not applicable | 40 |
Published literature
- 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
- Systematic review Clinical practice guidelines for switching or deprescribing hypnotic medications for chronic insomnia: Results of European neuropsychopharmacology and sleep expert's consensus groupPalagini L, Brugnoli R, Dell' Osso BM et al. · Sleep medicine · 2025 · PMID 39923608
- Cochrane review Comparative efficacy of hypnotics in young and middle-aged adults with insomnia: a systematic review and network meta-analysisHasan F, Lee HC, Chen PY et al. · Sleep & breathing = Schlaf & Atmung · 2023 · PMID 36928548
- Meta-analysis Efficacy and tolerability of pharmacological treatments for insomnia in adults: A systematic review and network meta-analysisYue JL, Chang XW, Zheng JW et al. · Sleep medicine reviews · 2023 · PMID 36701954
- 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
- Clinical trial publication Lemborexant for the Treatment of Insomnia: Direct and Indirect Comparisons With Other Hypnotics Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or HarmedCitrome L, Juday T, Frech F et al. · The Journal of clinical psychiatry · 2021 · PMID 34077032
- Meta-analysis Comparative efficacy of lemborexant and other insomnia treatments: a network meta-analysisMcElroy H, O'Leary B, Adena M et al. · Journal of managed care & specialty pharmacy · 2021 · PMID 34121443
- 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 Enhancement of zaleplon oral bioavailability using optimized self-nano emulsifying drug delivery systems and its effect on sleep quality among a sample of psychiatric patientsKhalifa MKA, Salem HA, Shawky SM et al. · Drug delivery · 2019 · PMID 31752566
- Clinical trial publication Patient Education and Pharmacist Consultation Influence on Nonbenzodiazepine Sedative Medication Deprescribing Success for Older AdultsKuntz JL, Kouch L, Christian D et al. · The Permanente journal · 2019 · PMID 30624198
- Cochrane review Drug treatment of primary insomnia: a meta-analysis of polysomnographic randomized controlled trialsWinkler A, Auer C, Doering BK et al. · CNS drugs · 2014 · PMID 25168785
- Clinical trial publication A double-blind, randomized, comparative study to evaluate the efficacy and safety of zaleplon versus zolpidem in shortening sleep latency in primary insomniaHuang YS, Hsu SC, Liu SI et al. · Chang Gung medical journal · 2011 · PMID 21392474
- Clinical trial publication Zaleplon increases nocturnal melatonin secretion in humansMorera AL, Abreu-Gonzalez P, Henry M · Progress in neuro-psychopharmacology & biological psychiatry · 2009 · PMID 19463883
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 Zaleplon approved for Insomnia / Sleep Disorders?
Zaleplon 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 Zaleplon in clinical trials for Insomnia / Sleep Disorders?
ClinicalTrials.gov lists 7 registered trials linking Zaleplon to Insomnia / Sleep Disorders: 1 is active or not yet recruiting; 6 have completed. The most advanced is Phase 2 (NCT01277107). The largest enrolment is 444 participants (NCT06640023). Registration activity spans 2004 to 2024.
What does the evidence show for Zaleplon in Insomnia / Sleep Disorders?
Zaleplon 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.