NCT03075241 is a Phase 3 clinical trial of Zolpidem in Sleep, sponsored by Brasilia University Hospital.

Who is sponsoring NCT03075241?

NCT03075241 is sponsored by Brasilia University Hospital.

What drugs are being tested in NCT03075241?

Interventions in NCT03075241: Zolpidem, Zoplicone, Placebo.

What condition does NCT03075241 study?

NCT03075241 studies Sleep, Sleep Disorders, Insomnia, Alzheimer's Disease.

Is NCT03075241 still recruiting?

NCT03075241 is currently completed. Last updated 8 November 2020.

Last reviewed 2020-11-08 · How we verify

NCT03075241

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Z-Drugs for the Treatment of Sleep Disorders in Alzheimer's Disease: a Randomized, Triple-blind, Placebo-controlled Study

Completed Phase 3 Last updated 8 November 2020

What this trial tests

Phase 3 trial testing Zolpidem in Sleep in 62 participants. Completed in 1 April 2020.

Timeline

1 October 2016

Primary endpoint
1 April 2020

1 April 2020

Quick facts

Lead sponsor	Brasilia University Hospital
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	62
Start date	1 October 2016
Primary completion	1 April 2020
Estimated completion	1 April 2020
Sites	1 location across Brazil

Drugs / interventions tested

Zolpidem (zolpidem) — full drug profile →
Zoplicone — full drug profile →
Placebo

Conditions studied

Sleep — all drugs for Sleep →
Sleep Disorders — all drugs for Sleep Disorders →
Insomnia — all drugs for Insomnia →
Alzheimer's Disease — all drugs for Alzheimer's Disease →

Sponsor

Brasilia University Hospital

Who can join

55 and older, any sex, with Sleep or Sleep Disorders. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Nighttime Total Sleep Time
Time frame: Baseline, 14 days follow-up
Mean Total Sleep Time (in minutes) during the 12h nocturnal period (8:00pm-8:00am) after 2 weeks under treatment

Sponsor's own description

The purpose of this study is to determine whether Zolpidem and Zoplicone are efective in the treatment of sleep disorders in Alzheimer's disease (AD)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Alzheimer's disease drug development pipeline: 2019.
Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2019 · cited 485× · PMID 31334330 · DOI 10.1016/j.trci.2019.05.008
Clinical trials of new drugs for Alzheimer disease.
Huang LK, Chao SP, Hu CJ. · · 2020 · cited 426× · PMID 31906949 · DOI 10.1186/s12929-019-0609-7
Alzheimer's disease drug development pipeline: 2018.
Cummings J, Lee G, Ritter A, Zhong K. · · 2018 · cited 402× · PMID 29955663 · DOI 10.1016/j.trci.2018.03.009
Alzheimer's disease drug development pipeline: 2020.
Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2020 · cited 350× · PMID 32695874 · DOI 10.1002/trc2.12050
Modulation of Brain Hyperexcitability: Potential New Therapeutic Approaches in Alzheimer's Disease.
Toniolo S, Sen A, Husain M. · · 2020 · cited 74× · PMID 33297460 · DOI 10.3390/ijms21239318
Pharmacotherapies for sleep disturbances in dementia.
McCleery J, Sharpley AL. · · 2020 · cited 62× · PMID 33189083 · DOI 10.1002/14651858.cd009178.pub4
Repurposed agents in the Alzheimer's disease drug development pipeline.
Bauzon J, Lee G, Cummings J. · · 2020 · cited 46× · PMID 32807237 · DOI 10.1186/s13195-020-00662-x
Proteostasis failure exacerbates neuronal circuit dysfunction and sleep impairments in Alzheimer's disease.
Morrone CD, Raghuraman R, Hussaini SA, Yu WH. · · 2023 · cited 40× · PMID 37085942 · DOI 10.1186/s13024-023-00617-4

Verify or expand the search:

Other trials of Zolpidem

Trials testing the same drug.

NCT06512155 — Improving Perioperative Sleep Disorders · Phase 1 · completed
NCT06244277 — Chinese Medicine Treatment of Adolescent Sleep Disorders and Sleeping Pills Withdrawal · NA · unknown
NCT06084130 — Zolpidem on CPAP Acclimatization in OSA · Phase 4 · unknown
NCT05540574 — Trial of Zolpidem for Sleep in Children With Autism · Phase 2 · recruiting
NCT04468776 — CBT-I or Zolpidem/Trazodone for Insomnia · Phase 4 · completed

Other recruiting trials for Sleep

Currently open trials in the same condition.

NCT07413185 — Relationship Between the Severity of Sleep Deprivation in the First 48 Hours Postpartum, Breastfeeding Motivation, and B · recruiting
NCT07401212 — GUTLINK4KIDS Intervention · NA · recruiting
NCT07497698 — Saffron Extract Supplementation and Sleep Quality in Middle-Aged Adults · NA · recruiting
NCT07213908 — Comparing Two School-Based Sleep Health Interventions To Promote Sleep Quality in Youth · NA · recruiting
NCT06670287 — The Use of Multiple Sensors to Track Sleep in Nightshift Workers · NA · recruiting

Other Brasilia University Hospital trials

Trials by the same sponsor.

NCT04291794 — Mean Arterial Pressure Reduction Anesthesia Induction Using Propofol Bolus or Tritiated Target-infusion · Phase 4 · unknown
NCT04288466 — Gastric Emptying of Maltodextrin Solution in Elderly and in Adults · NA · unknown
NCT03725228 — Lidocaine Compared to Magnesium Sulfate to Prolong Spinal Anesthesia: Non-inferiority Randomized Clinical Trial · Phase 4 · completed
NCT03595319 — Median Sevoflurane Concentration for Hypotension Between Young and Elderlypatients: Adaptive Clinical Trial · Phase 4 · unknown
NCT03805282 — Intravenous Lidocaine to Supress of Cough Reflex During Anesthesia Emergence · Phase 3 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03075241 (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 Brasilia University Hospital
Last refreshed: 8 November 2020

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/NCT03075241.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing