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zolipidem
zolipidem is a Small molecule drug developed by Shriners Hospitals for Children. It is currently in Phase 2 development. Also known as: Ambien.
Zolpidem is a medication used in studies related to sleep and bioequivalence. It is available in 10mg tablet form and has been studied for its relative bioavailability under fasting conditions.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | zolipidem |
|---|---|
| Also known as | Ambien |
| Sponsor | Shriners Hospitals for Children |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Differential Effects of Zolpidem Versus Ramelteon in Burned Children (PHASE2)
- Bioequivalence Study of Zolpidem 10mg Tablets Under Fasting Conditions (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- zolipidem CI brief — competitive landscape report
- zolipidem updates RSS · CI watch RSS
- Shriners Hospitals for Children portfolio CI
Frequently asked questions about zolipidem
What is zolipidem?
Who makes zolipidem?
Is zolipidem also known as anything else?
What development phase is zolipidem in?
Related
- Manufacturer: Shriners Hospitals for Children — full pipeline
- Therapeutic area: All drugs in Metabolic
- Also known as: Ambien
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing