Summary
Pentobarbital 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 1 registered trial linking Pentobarbital to Insomnia / Sleep Disorders: 1 has completed. None of the registered studies carries a drug-development phase label, which is typical for behavioural, device and supplement protocols. It plans or enrolled 3520 participants. Registered activity dates to 2011. The literature layer holds 5 publications for this pair: 5 clinical trial publications. Publication years run from 1976 to 1992. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
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 | 32.5 (trials 2.5, literature 10.0, tier 15, approved bonus 5.0) |
| Registered trials | 1 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 0 other |
| Linked publications | 5 (5 clinical trial publications) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01431326 | Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care 2011 | completed | Not applicable | 3,520 |
Published literature
- Clinical trial publication [Periodic discharges of sleep spindles with placebo and zopiclone]Spieweg I, Sanders S, Kubicki S · EEG-EMG Zeitschrift fur Elektroenzephalographie, Elektromyographie und verwandte Gebiete · 1992 · PMID 1486827
- Clinical trial publication Efficacy and side effects of flunitrazepam and pentobarbital in severely insomniac patientsLinnoila M, Erwin CW, Brendle A · Journal of clinical pharmacology · 1982 · PMID 6120958
- Clinical trial publication [Lormetazepam in preoperative sleeplessness. Dose dependance of the effect and comparison with 100 mg pentobarbital (author's transl)]Ott H, Doenicke A, Abress C et al. · Der Anaesthesist · 1979 · PMID 32799
- Clinical trial publication A subjective and objective method assessing the efficacy of hypnotic medications in insomniacsWang RI, Stockdale SL · Journal of clinical pharmacology · 1977 · PMID 336652
- Clinical trial publication Effectiveness of intermediate-term use of secobarbitalKales A, Hauri P, Bixler EO et al. · Clinical pharmacology and therapeutics · 1976 · PMID 185000
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 Pentobarbital approved for Insomnia / Sleep Disorders?
Pentobarbital 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 Pentobarbital in clinical trials for Insomnia / Sleep Disorders?
ClinicalTrials.gov lists 1 registered trial linking Pentobarbital to Insomnia / Sleep Disorders: 1 has completed. None of the registered studies carries a drug-development phase label, which is typical for behavioural, device and supplement protocols. It plans or enrolled 3520 participants. Registered activity dates to 2011.
What does the evidence show for Pentobarbital in Insomnia / Sleep Disorders?
Pentobarbital has 1 completed trial and 5 linked publications for Insomnia / Sleep Disorders. Completed trials may or may not have posted results; follow the NCT links to check. 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.