Last reviewed · How we verify
NCT01896336
Efficacy and Safety of 5 mg Sublingual Zolpidem vs 10mg Oral Zolpidem in the Induction and Maintenance of Sleep in Patients With Primary Insomnia
Phase 4 trial testing Zolpidem Hemitartrate in Primary Insomnia in 67 participants. Completed in 10 December 2013.
11 November 2013
Quick facts
| Lead sponsor | EMS |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 67 |
| Start date | 18 February 2013 |
| Primary completion | 11 November 2013 |
| Estimated completion | 10 December 2013 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Zolpidem Hemitartrate — full drug profile →
Conditions studied
- Primary Insomnia — all drugs for Primary Insomnia →
Sponsor
EMS — full company profile →
Who can join
Adults 20 to 64, any sex, with Primary Insomnia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the efficacy and safety of sublingual zolpidem presentation 5 mg in the induction of sleep in patients with primary insomnia.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trial.
Castro LS, Otuyama LJ, Fumo-Dos-Santos C, Tufik S, et al · · 2020 · cited 6× · PMID 31859791 · DOI 10.1590/1516-4446-2019-0389
Verify or expand the search:
- PubMed search for NCT01896336
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Primary Insomnia
Currently open trials in the same condition.
- NCT06996171 — Comparative Efficacy of Magnesium Supplement and Melatonin Congener in Young Adults With Primary Insomnia · NA · recruiting
- NCT06782815 — Acupoint Selection Based on Meridian Theory in Primary Insomnia of Liver Depression and Spleen Deficiency Type · NA · recruiting
- NCT05830877 — The Study on the Evaluation of Acupuncture Therapy on Primary Insomnia · NA · recruiting
Other EMS trials
Trials by the same sponsor.
- NCT05640232 — Efficacy and Safety of CDE100 in the Treatment of Menstrual Cramp Pain Associated With Primary Dysmenorrhea · Phase 3 · recruiting
- NCT06237231 — Efficacy and Safety of DIT112 in the Treatment of Moderate to Severe Pain After Dental Surgery for the Extraction of Imp · Phase 3 · not yet recruiting
- NCT06272409 — Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children. · Phase 3 · not yet recruiting
- NCT05800392 — Efficacy and Safety of DEC103 in Pain Control Associated to Intrauterine Device (IUD) Insertion · Phase 4 · completed
- NCT04666714 — Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01896336 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by EMS
- Last refreshed: 24 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01896336.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing