Summary
Doxepin Hydrochloride 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 5 registered trials linking Doxepin Hydrochloride to Insomnia / Sleep Disorders: 1 is currently recruiting; 1 is active or not yet recruiting; 3 have completed. The most advanced is Phase 4 (NCT07542756). It plans or enrolled 1200 participants. Registration activity spans 2006 to 2026. No published literature item is linked to Doxepin Hydrochloride and Insomnia / Sleep Disorders in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
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 | 40.0 (trials 20.0, literature 0.0, tier 15, approved bonus 5.0) |
| Registered trials | 5 total: 1 recruiting, 1 active / not yet recruiting, 3 completed, 0 other |
| Linked publications | 0 |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
| NCT07598734 | Doxepin Alone or Combined With Ramelteon Versus Placebo for Improving Sleep Quality After Primary Total Knee Arthroplasty 2026 | not yet recruiting | Phase 4 | 129 |
| NCT07542756 | A SMART Approach to Evaluating the Benefits of Common Prescription and OTC Medications for Insomnia 2026 | recruiting | Phase 4 | 1,200 |
| NCT00755495 | Safety and Efficacy of Ramelteon and Doxepin in Subjects With Chronic Insomnia 2006 | completed | Phase 2 | 472 |
| NCT01489982 | Treatments for Insomnia in Patients With Parkinson's Disease 2011 | completed | Early Phase 1 | 20 |
Published literature
No publication is linked to this pair yet.
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 Doxepin Hydrochloride approved for Insomnia / Sleep Disorders?
Doxepin Hydrochloride 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 Doxepin Hydrochloride in clinical trials for Insomnia / Sleep Disorders?
ClinicalTrials.gov lists 5 registered trials linking Doxepin Hydrochloride to Insomnia / Sleep Disorders: 1 is currently recruiting; 1 is active or not yet recruiting; 3 have completed. The most advanced is Phase 4 (NCT07542756). It plans or enrolled 1200 participants. Registration activity spans 2006 to 2026.
What does the evidence show for Doxepin Hydrochloride in Insomnia / Sleep Disorders?
Doxepin Hydrochloride has 3 completed registered trials for Insomnia / Sleep Disorders but no linked publication, which usually means results are unpublished, pending, or not yet matched to this record. 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.