NCT03885141 (ZOLP_18_01) is a Phase 2/Phase 3 clinical trial of Zolpidem in Insomnia Disorder, sponsored by Biolab Sanus Farmaceutica.

Who is sponsoring NCT03885141?

NCT03885141 is sponsored by Biolab Sanus Farmaceutica.

What drugs are being tested in NCT03885141?

Interventions in NCT03885141: Zolpidem.

What condition does NCT03885141 study?

NCT03885141 studies Insomnia Disorder.

Is NCT03885141 still recruiting?

NCT03885141 is currently status unknown. Last updated 24 July 2020.

Last reviewed 2020-07-24 · How we verify

NCT03885141: ZOLP_18_01

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

Phase II / III Study, One Center, Double-Blind, With Placebo Use, in Parallel Groups to Assess the Efficacy and Safety of Zolpidem® Orodispersible in Adult Subjects (Females and Males) in the Treatment of Maintenance Insomnia Disorder.

Status unknown Phase 2/Phase 3 Last updated 24 July 2020

What this trial tests

Phase 2/Phase 3 trial testing Zolpidem in Insomnia Disorder in 366 participants. Status unknown.

Timeline

1 March 2021

Primary endpoint
1 December 2021

1 December 2021

Quick facts

Lead sponsor	Biolab Sanus Farmaceutica
Phase	Phase 2/Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	366
Start date	1 March 2021
Primary completion	1 December 2021
Estimated completion	1 December 2021

Drugs / interventions tested

Zolpidem (zolpidem) — full drug profile →

Conditions studied

Insomnia Disorder — all drugs for Insomnia Disorder →

Sponsor

Biolab Sanus Farmaceutica — full company profile →

Who can join

Adults 18 to 64, any sex, with Insomnia Disorder. 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.

Difference Insomnia Severity Index (ISI) as assessed by questionnaire before treatment and after the treatment
Time frame: 28 days
To analyse the efficacy of Zolpidem® Orodispersible treatment 1.0 mg or 1.75 mg in women and 1.75 mg and 3.5 mg in men, compared to placebo, after taking the medication when a spontaneous wake up occurs during 28 days. The assessement will be performed by means of the standard questionnaire before and at the end of the treatment period. The computed mean difference for each treatment will be compa

Sponsor's own description

Biolab Sanus is developing a product in the form of orodispersible tablet containing 1.0 mg, 1.75 mg and 3.5 mg of Zolpidem®. Thus, it is intended to evaluate the efficacy of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women and Zolpidem Orodispersible 1.75 mg or 3.5 mg in men for the improvement of the maintenance insomnia disorder, through the evaluation of the Insomnia Severity Index, and using a Sleep Diary throughout the study, as well as to evaluate the latency of the sleep after a spontaneous or provoked wake up measured by polysomnography.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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 Insomnia Disorder

Currently open trials in the same condition.

NCT06767137 — Comparative Efficacy of BRT and CBT-I for Insomnia · NA · recruiting
NCT06626048 — Optimizing an Integrated Mind and Body Treatment for Insomnia: The SLEEPS Study · NA · active not recruiting
NCT06669507 — The Sleep Clinic Outcome and Practice Study · NA · recruiting
NCT06335784 — Mental Imagery and Targeted Memory Reactivation in Insomnia · NA · recruiting
NCT05924425 — Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease · Phase 4 · recruiting

Other Biolab Sanus Farmaceutica trials

Trials by the same sponsor.

NCT06564883 — Hydration and Acceptability of the Genital and Skin Mucosa of a Vaginal Moisturizer in Menopausal Women · Phase 3 · not yet recruiting
NCT04880889 — BL3000 Compared to Pantogar® in the Treatment of Telogen Effluvium in Women. · Phase 3 · unknown
NCT04729088 — Pharmacokinetics Trial of Isosorbide Mononitrate 0.5% Gel for Intra Anal Application in Healthy Subjects · Phase 1 · withdrawn
NCT03320486 — Non-inferiority Trial of Dapaconazole Versus Ketoconazole · Phase 3 · completed
NCT02817750 — Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 3.5 mg Formulation · Phase 1 · completed

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 NCT03885141 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biolab Sanus Farmaceutica
Last refreshed: 24 July 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/NCT03885141.

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