Zolpidem

Generic Name: Zolpidem

Brand Names: Ambien, Edluar, Intermezzo, Tovalt

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₂₁N_₃O

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 s...

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

Associated Conditions: Insomnia

Associated Therapies: -

Clinical Trials

Alternative Dosing Regimens in the Pharmacotherapy of Insomnia

Phase 3

Terminated

Conditions: Insomnia

Interventions: Drug: Amitriptyline
Drug: Zolpidem
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: Drug: Midazolam
Drug: zolpidem

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

Proton MRS Study of SSRI-Zolpidem Interactions

Early Phase 1

Completed

Conditions: Depression

Interventions: Drug: Zolpidem
Other: Placebo

First Posted Date: 2013-03-13

Last Posted Date: 2013-03-13

Lead Sponsor: Mclean Hospital

Target Recruit Count: 14

Registration Number: NCT01809626

Locations: 🇺🇸
McLean Hospital, Belmont, Massachusetts, United States

Two Contrasting Interventions for Sleep Management

Phase 2

Completed

Conditions: Primary Insomnia
Secondary Insomnia

Interventions: Behavioral: Mind-Body Bridging
Drug: Zolpidem

First Posted Date: 2013-03-05

Last Posted Date: 2017-03-30

Lead Sponsor: University of Utah

Target Recruit Count: 72

Registration Number: NCT01804036

Locations: 🇺🇸
University of Utah, Salt Lake City, Utah, United States
🇺🇸
Evans Army Community Hospital, Colorado Springs, Colorado, United States

Imaging the Effects of Zolpidem and Alprazolam in Healthy Volunteers at 3T

Early Phase 1

Conditions: Psychotropic Drugs Effects

Interventions: Drug: Zolpidem
Drug: Alprazolam
Drug: Caffeine
Other: Placebo

First Posted Date: 2012-12-11

Last Posted Date: 2012-12-11

Lead Sponsor: Mclean Hospital

Target Recruit Count: 12

Registration Number: NCT01747590

Locations: 🇺🇸
McLean Hospital, Belmont, Massachusetts, United States

Sequenced Therapies for Comorbid and Primary Insomnias

Not Applicable

Completed

Conditions: Insomnia Comorbid to Psychiatric Disorder
Primary Insomnia

Interventions: Behavioral: Cognitive Therapy
Behavioral: Behavioral Insomnia Therapy
Drug: Zolpidem
Drug: Trazodone

First Posted Date: 2012-07-27

Last Posted Date: 2021-03-29

Lead Sponsor: Jack Edinger, PhD

Target Recruit Count: 211

Registration Number: NCT01651442

Locations: 🇨🇦
Université Laval, Quebec City, Quebec, Canada
🇺🇸
National Jewish Health, Denver, Colorado, United States

Postoperative Sleep Disturbances After Zolpidem Treatment in Fast-track Hip and Knee Replacement

Not Applicable

Conditions: Sleep Duration on the First Night After Surgery

Interventions: Drug: Zolpidem
Drug: Placebo

First Posted Date: 2012-03-12

Last Posted Date: 2012-08-08

Lead Sponsor: Rigshospitalet, Denmark

Target Recruit Count: 20

Registration Number: NCT01551485

Locations: 🇩🇰
Gentofte Hospital, Gentofte, Denmark

Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep

Not Applicable

Completed

Conditions: Insomnia

Interventions: Drug: Dexmedetomidine
Drug: Zolpidem

First Posted Date: 2011-12-05

Last Posted Date: 2019-10-08

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 10

Registration Number: NCT01485393

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Sleep Satisfaction and Psychomotor Performance of Adults

Phase 4

Completed

Conditions: Sleep Disorders

Interventions: Drug: ZOLPIDEM

First Posted Date: 2010-04-01

Last Posted Date: 2012-07-17

Lead Sponsor: Sanofi

Target Recruit Count: 30

Registration Number: NCT01097382

Locations: 🇦🇷
Investigational Site Number 4, C.a.b.a., Argentina
🇦🇷
Investigational Site Number 10, Buenos Aires, Argentina
🇦🇷
Investigational Site Number 1, C.a.b.a., Argentina

and more 3 locations

Safety and Efficacy of Chronic Hypnotic Use

Completed

Conditions: Primary Insomnia

Interventions: Drug: zolpidem

First Posted Date: 2009-11-03

Last Posted Date: 2011-11-06

Lead Sponsor: Henry Ford Health System

Target Recruit Count: 116

Registration Number: NCT01006525

Locations: 🇺🇸
Henry Ford Sleep and Research Center, Detroit, Michigan, United States

Drug Development Updates

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