Suvorexant
| 證據等級: L5 | 預測適應症: 1 個 |
目錄
- Suvorexant
- Suvorexant: From Undetermined Original Indication to Insomnia (Sleep Initiation and Maintenance Disorder)
Suvorexant: From Undetermined Original Indication to Insomnia (Sleep Initiation and Maintenance Disorder)
One-Sentence Summary
The evidence pack does not specify Suvorexant’s original approved indication or mechanism of action (both flagged as data gaps). The TxGNN model predicts it may be effective for Insomnia (Sleep Disorder, Initiating and Maintaining Sleep), with 1 clinical trial (withdrawn) and 20 publications currently supporting this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not specified in evidence pack |
| Predicted New Indication | Insomnia (Sleep Disorder, Initiating and Maintaining Sleep) |
| TxGNN Prediction Score | 99.74% |
| Evidence Level | L1 |
| US Market Status | Not Marketed |
| Number of NDAs | 0 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data for Suvorexant is not available in the evidence pack. However, the supporting literature consistently identifies Suvorexant as a dual orexin receptor antagonist (DORA), blocking OX1R/OX2R signaling to suppress the wake-promoting orexin system and thereby facilitate sleep onset and maintenance (see Muehlan et al. 2023; Wu et al. 2022; Żełabowski et al. 2025).
The predicted indication — sleep disorder, initiating and maintaining sleep — aligns directly with this orexin-antagonist mechanism, and the literature evidence includes what appears to be the original pivotal Phase 3 program for Suvorexant in insomnia (Herring et al. 2016, “Results From Two 3-Month Randomized Controlled Clinical Trials”). This, combined with over a dozen subsequent systematic reviews and network meta-analyses comparing Suvorexant against other DORAs (lemborexant, daridorexant) and standard hypnotics, indicates the mechanism-indication link is well established in the published literature, even though structured MOA and original-indication fields were not populated in this evidence pack.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT03764683 | Phase 4 | Withdrawn | 0 | Planned double-blind study of Suvorexant (Belsomra) added to usual treatment for insomnia in bipolar depression; trial was withdrawn with zero enrollment, so no efficacy/safety data were generated. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 25526970 | 2016 | RCT | Biological Psychiatry | Reports results from two pivotal 3-month Phase 3 RCTs establishing Suvorexant’s efficacy as an orexin receptor antagonist for insomnia. |
| 40555730 | 2025 | Systematic Review/NMA | Translational Psychiatry | Network meta-analysis comparing efficacy/safety of daridorexant, lemborexant, and suvorexant for insomnia. |
| 36947394 | 2023 | Systematic Review/NMA | Drugs | Large-scale NMA of 153 RCTs comparing effectiveness, safety, and tolerability of insomnia drugs including suvorexant. |
| 35843245 | 2022 | Systematic Review/NMA | The Lancet | Comparative effectiveness of pharmacological interventions, including suvorexant, for acute and long-term insomnia management. |
| 39277609 | 2024 | Systematic Review | Translational Psychiatry | Reviews evidence for lemborexant and suvorexant as treatments for insomnia comorbid with psychiatric disorders (depression, bipolar disorder). |
| 37257468 | 2023 | Systematic Review/NMA | Arquivos de Neuro-Psiquiatria | Confirms efficacy of dual orexin receptor antagonists, including suvorexant, for chronic insomnia via RCT-based network meta-analysis. |
| 32531478 | 2020 | Systematic Review/NMA | Journal of Psychiatric Research | NMA of 4 double-blind RCTs (n=3237) comparing lemborexant vs suvorexant efficacy and safety outcomes. |
| 34121443 | 2021 | Systematic Review/NMA | J Managed Care & Specialty Pharmacy | Compares efficacy/safety of lemborexant and suvorexant against other insomnia treatments via NMA. |
| 38460107 | 2024 | Open-label Clinical Study | Advances in Therapy | Multicenter study evaluating transition from suvorexant (and other agents) to lemborexant in Japanese insomnia patients. |
| 37086045 | 2023 | Review | Journal of Sleep Research | Reviews orexin biology and orexin receptor antagonists, including suvorexant, in insomnia treatment. |
US Market Information
Suvorexant is currently not marketed in this jurisdiction — the evidence pack contains no license or NDA records (0 total licenses).
Safety Considerations
Please refer to the package insert for safety information. No structured key warnings, contraindications, or drug interaction data were available in this evidence pack (DDI query status: not found).
Conclusion and Next Steps
Decision: Hold
Rationale: Efficacy evidence for the predicted indication is strong (L1 — established Phase 3 RCT evidence plus extensive corroborating systematic reviews/network meta-analyses), but a Blocking data gap exists: TFDA-equivalent label warnings and contraindications are entirely unavailable, which prevents completion of the S1 safety pre-assessment. The drug also has zero existing domestic marketing authorizations.
To proceed, the following is needed:
- Official package insert / label data (warnings, contraindications, DDI) — download and parse from the relevant regulatory agency (resolves DG001, Blocking)
- Confirmed mechanism of action via DrugBank API query (resolves DG002)
- Clarification of Suvorexant’s originally approved indication(s), whether domestic or reference-market
- Regulatory pathway assessment given current zero-license market status before any repurposing submission
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.