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
Partial Reinforcement II: Three Approaches to Maintenance Therapy for Chronic Insomnia
- First Posted Date
- 2018-12-13
- Last Posted Date
- 2025-05-09
- Lead Sponsor
- University of Pennsylvania
- Target Recruit Count
- 197
- Registration Number
- NCT03774810
- Locations
- 🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users
- Conditions
- Healthy Recreational Drug Users
- Interventions
- First Posted Date
- 2018-09-05
- Last Posted Date
- 2019-09-19
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Target Recruit Count
- 63
- Registration Number
- NCT03657355
- Locations
- 🇨🇦
Altasciences Company Inc., Montreal, Canada
🇺🇸Altasciences Clinical Kansas, Inc. (former Vince and Associates Clinical Research, Inc.), Overland Park, Kansas, United States
Enhancing Memory Consolidation in Older Adults
- First Posted Date
- 2018-09-04
- Last Posted Date
- 2025-02-05
- Lead Sponsor
- University of California, Irvine
- Target Recruit Count
- 10
- Registration Number
- NCT03657212
- Locations
- 🇺🇸
Sleep and Cognition Lab, Irvine, California, United States
Use of Low-dose Zolpidem in Parkinson's Disease
- First Posted Date
- 2018-08-08
- Last Posted Date
- 2020-03-27
- Lead Sponsor
- Aston University
- Target Recruit Count
- 28
- Registration Number
- NCT03621046
- Locations
- 🇬🇧
University Hospitals Birmingham NHS Foundation Trust, Birmingham, West Midlands, United Kingdom
Optimize Astronaut Sleep Medication Efficacy and Individual Effects
- First Posted Date
- 2018-05-16
- Last Posted Date
- 2018-05-16
- Lead Sponsor
- National Aeronautics and Space Administration (NASA)
- Target Recruit Count
- 34
- Registration Number
- NCT03526575
The Effects of Castration on the Pharmacokinetics of Zolpidem After Single Dose Administration In Men With Prostate Cancer Undergoing Androgen Deprivation Therapy Compared to Normal Healthy Females
- First Posted Date
- 2018-02-19
- Last Posted Date
- 2025-02-11
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 12
- Registration Number
- NCT03436745
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
A Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Participants With Insomnia Disorder
- Conditions
- Insomnia Disorders
- Interventions
- Drug: PlaceboDrug: JNJ-42847922, 5 mgDrug: JNJ-42847922, 20 mgDrug: JNJ-42847922, 10 mg
- First Posted Date
- 2017-12-15
- Last Posted Date
- 2025-04-29
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 365
- Registration Number
- NCT03375203
- Locations
- 🇺🇸
Avail Clinical Research, LLC, DeLand, Florida, United States
🇺🇸Sarkis Clinical Trials, Lake City, Florida, United States
🇺🇸Suncoast Research Group, Miami, Florida, United States
Improving Sleep Quality in Heart Failure
- Conditions
- Heart FailureSleep Disturbance
- Interventions
- Drug: Placebo oral capsule
- First Posted Date
- 2017-10-11
- Last Posted Date
- 2020-02-11
- Lead Sponsor
- Johns Hopkins University
- Target Recruit Count
- 5
- Registration Number
- NCT03307005
- Locations
- 🇺🇸
Johns Hopkins Bayview Campus, Asthma and Allergy Center, Baltimore, Maryland, United States
Sedative-Anxiolytic Effects on Simulated Driving Performance
- Conditions
- Psychomotor Impairment
- Interventions
- First Posted Date
- 2017-09-29
- Last Posted Date
- 2020-01-29
- Lead Sponsor
- Marion Coe
- Target Recruit Count
- 15
- Registration Number
- NCT03297944
- Locations
- 🇺🇸
Center on Drug and Alcohol Research, Lexington, Kentucky, United States
Multimodal Sleep Pathway for Shoulder Arthroplasty
- Conditions
- Shoulder ArthritisPerioperative/Postoperative ComplicationsArthroplasty ComplicationsSleep Disturbance
- Interventions
- First Posted Date
- 2017-09-01
- Last Posted Date
- 2020-05-27
- Lead Sponsor
- University of California, San Francisco
- Target Recruit Count
- 122
- Registration Number
- NCT03269760
- Locations
- 🇺🇸
Ucsf, San Francisco, California, United States
Drug Development Updates
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