MedPath

Zolpidem

Generic Name
Zolpidem
Brand Names
Ambien, Edluar, Intermezzo, Tovalt
Drug Type
Small Molecule
Chemical Formula
C19H21N3O
CAS Number
82626-48-0
Unique Ingredient Identifier
7K383OQI23
Background

Zolpidem, also known as Ambien, is a hypnotic drug that was initially approved by the FDA in 1992 . Zolpidem improves sleep in patients with insomnia. It is aimed for use in patients with difficulties initiating sleep. This drug decreases the time to fall asleep (sleep latency), increases the duration of sleep, and decreases the number of awakenings during sleep in patients with temporary (transient) insomnia. It is available in both immediate acting and extended release forms , .

Its tolerability profile is favorable when administered according to the manufacturer’s instructions, with a low risk of drug withdrawal, drug dependence, and drug tolerance . In addition, zolpidem improves sleep quality in patients suffering from chronic insomnia and can show mild muscle relaxant properties . Research also shows that zolpidem is rapid and effective in restoring brain function for patients in a vegetative state following brain injury. This drug has the propensity to completely or partially reverse the abnormal metabolism of damaged brain cells after injury , .

Indication

This drug is indicated for the short-term treatment of insomnia in adults characterized by difficulties with sleep initiation .

Associated Conditions
Insomnia
Clinical Trials
Related News

Pharmacokinetics of Zolpidem Orodispersible Tablet

Phase 1
Withdrawn
Conditions
Healthy Volunteers
Interventions
First Posted Date
2015-11-18
Last Posted Date
2017-02-01
Lead Sponsor
Biolab Sanus Farmaceutica
Registration Number
NCT02607696

Pilot Study to Evaluate the Duration of Effects on Simulated Car Driving and Cognitive Performance After a Single Dose of JNJ-42847922, Zolpidem and Placebo in Healthy Participants

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Placebo
First Posted Date
2015-10-19
Last Posted Date
2016-03-24
Lead Sponsor
Janssen-Cilag International NV
Target Recruit Count
36
Registration Number
NCT02578472

The Study of Spectrum of Sleep Disorders in Cirrhotic Patients and the Efficacy of Zolpidem in Cirrhotic Patients With Insomnia

Not Applicable
Completed
Conditions
Cirrhosis
Interventions
Drug: placebo
First Posted Date
2015-06-30
Last Posted Date
2018-05-17
Lead Sponsor
Institute of Liver and Biliary Sciences, India
Target Recruit Count
52
Registration Number
NCT02484963
Locations
🇮🇳

Institute of Liver and Biliary Sciences, New Delhi, Delhi, India

Safety and Efficacy of Chronic Hypnotic Use 2

Phase 4
Completed
Conditions
Chronic Insomnia
Interventions
Drug: placebo
First Posted Date
2015-05-28
Last Posted Date
2024-03-29
Lead Sponsor
Henry Ford Health System
Target Recruit Count
41
Registration Number
NCT02456532
Locations
🇺🇸

HFHS Sleep Disorders Ctr, Detroit, Michigan, United States

Pharmacovigilance in Gerontopsychiatric Patients

Phase 3
Terminated
Conditions
Dementia
Depression
Schizophrenia
Psychosomatic Disorders
Anxiety Disorders
Interventions
First Posted Date
2015-03-02
Last Posted Date
2018-02-28
Lead Sponsor
Hannover Medical School
Target Recruit Count
407
Registration Number
NCT02374567
Locations
🇩🇪

Bezirkskrankenhaus Augsburg, Augsburg, Germany

🇩🇪

Krankenhaus Hedwigshöhe, Berlin, Germany

🇩🇪

Hannover Medical School, Hannover, Germany

and more 2 locations

Assess the Effect of Zolpidem, Silenor & Placebo on Arousability, Ataxia/Balance & Cognition in Healthy Volunteers

Phase 4
Completed
Conditions
Healthy
Interventions
Drug: Placebo
First Posted Date
2015-02-02
Last Posted Date
2018-01-02
Lead Sponsor
Currax Pharmaceuticals
Target Recruit Count
52
Registration Number
NCT02353299
Locations
🇺🇸

Henry Ford Hospital Sleep Disorders & Research Center, Novi, Michigan, United States

Alternative Dosing Regimens in the Pharmacotherapy of Insomnia

Phase 3
Terminated
Conditions
Insomnia
Interventions
Drug: Placebo
First Posted Date
2014-05-15
Last Posted Date
2018-03-09
Lead Sponsor
Philipps University Marburg Medical Center
Target Recruit Count
23
Registration Number
NCT02139098
Locations
🇩🇪

Clinical Psychology and Psychotherapy, Department of Psychology, Philipps University Marburg, Marburg, Hessen, Germany

A Comparison of Midazolam and Zolpidem as Oral Premedication in Children

Phase 3
Completed
Conditions
Child's Anxiety
Parental/Caregiver Anxiety
Interventions
First Posted Date
2014-03-26
Last Posted Date
2019-03-14
Lead Sponsor
Loma Linda University
Target Recruit Count
86
Registration Number
NCT02096900
Locations
🇺🇸

Loma Linda University, Loma Linda, California, United States

Study to Evaluate the Relative Abuse Potential of Almorexant in Recreational Drug Users

First Posted Date
2013-11-19
Last Posted Date
2016-02-12
Lead Sponsor
Midnight Pharma, LLC
Target Recruit Count
42
Registration Number
NCT01987739

Effects of Zolpidem CR® in Sleep and Heart Recovery in Cardiac Intensive Care Unit Patients

Phase 4
Conditions
Acute Coronary Syndrome
Sleep Deprivation
Interventions
Drug: Placebo
First Posted Date
2013-08-12
Last Posted Date
2013-08-12
Lead Sponsor
Associação Fundo de Incentivo à Pesquisa
Target Recruit Count
100
Registration Number
NCT01920334
Locations
🇧🇷

Hospital São Paulo, Sao Paulo, SP, Brazil

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy