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
Zolpidem or Exercise for Insomnia?
- First Posted Date
- 2017-05-19
- Last Posted Date
- 2021-03-01
- Lead Sponsor
- Universidade Federal de Goias
- Target Recruit Count
- 34
- Registration Number
- NCT03160404
- Locations
- 🇧🇷
Hospital Padre Thiago, jATAÍ, GO, Brazil
A Study to Determine the Abuse Potential of Single Oral Doses of Lemborexant Compared to Zolpidem, Suvorexant and Placebo in Healthy, Non-Dependent, Recreational Sedative Users
- Conditions
- Insomnia Disorders
- Interventions
- First Posted Date
- 2017-05-17
- Last Posted Date
- 2020-06-29
- Lead Sponsor
- Eisai Inc.
- Target Recruit Count
- 39
- Registration Number
- NCT03158025
- Locations
- 🇨🇦
INC Research Toronto, Inc., Toronto, Canada
Z-Drugs for Sleep Disorders in Alzheimer's Disease
- Conditions
- SleepInsomniaSleep DisordersAlzheimer's Disease
- Interventions
- First Posted Date
- 2017-03-09
- Last Posted Date
- 2020-11-10
- Lead Sponsor
- Brasilia University Hospital
- Target Recruit Count
- 62
- Registration Number
- NCT03075241
- Locations
- 🇧🇷
Geriatric Medical Centre, Brasilia, Distrito Federal, Brazil
Study to Validate the Questionnaire Called IDSIQ™ in Patients With Insomnia Disorder
- First Posted Date
- 2017-02-17
- Last Posted Date
- 2019-07-24
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Target Recruit Count
- 113
- Registration Number
- NCT03056053
- Locations
- 🇺🇸
Santa Monica Clinical Trials, Santa Monica, California, United States
🇺🇸Neurotrials Research Inc, Atlanta, Georgia, United States
🇩🇪CTC North, Universitätsklinikum Hamburg- Eppendorf, Hamburg, Germany
A Promising Tool for Predicting Consciousness Evolution in Prolonged Disorders of Consciousness
- First Posted Date
- 2016-10-28
- Last Posted Date
- 2022-05-31
- Lead Sponsor
- Xijing Hospital
- Target Recruit Count
- 36
- Registration Number
- NCT02948660
- Locations
- 🇨🇳
Department of Neurology, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi, China
Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
- Conditions
- Insomnia Disorder
- Interventions
- Drug: Placebo 1Drug: Placebo 2
- First Posted Date
- 2016-07-20
- Last Posted Date
- 2020-04-13
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Target Recruit Count
- 360
- Registration Number
- NCT02839200
- Locations
- 🇸🇪
Investigator Site, Örebro, Sweden
Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 3.5 mg Formulation
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2016-06-29
- Last Posted Date
- 2018-06-11
- Lead Sponsor
- Biolab Sanus Farmaceutica
- Target Recruit Count
- 28
- Registration Number
- NCT02817750
- Locations
- 🇧🇷
UNIFAG - Unidade Integrada de Farmacologia e Gastroenterologia, Bragança Paulista, SP, Brazil
Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 1.75 mg Formulation
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2016-06-27
- Last Posted Date
- 2018-06-08
- Lead Sponsor
- Biolab Sanus Farmaceutica
- Target Recruit Count
- 28
- Registration Number
- NCT02814058
- Locations
- 🇧🇷
UNIFAG - Unidade Integrada de Farmacologia e Gastroenterologia, Bragança Paulista, SP, Brazil
Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)
- Conditions
- Insomnia
- Interventions
- Drug: Lemborexant-matched placeboDrug: Zolpidem-matched placebo
- First Posted Date
- 2016-05-26
- Last Posted Date
- 2024-11-12
- Lead Sponsor
- Eisai Inc.
- Target Recruit Count
- 1006
- Registration Number
- NCT02783729
- Locations
- 🇺🇸
Saint Francis Sleep Allergy and Lung Institute, Clearwater, Florida, United States
🇨🇦Toronto Sleep Institute, Toronto, Ontario, Canada
🇺🇸University of Pennsylvania, Philadelphia, Pennsylvania, United States
Hypnotic Intake and Motor and Cognitive Performances at High Altitude
- First Posted Date
- 2016-05-20
- Last Posted Date
- 2018-01-05
- Lead Sponsor
- Centre d'Expertise sur l'Altitude EXALT
- Target Recruit Count
- 22
- Registration Number
- NCT02778659
- Locations
- 🇫🇷
Grenoble University Hospital, Grenoble, Rhone Alpes, France
Drug Development Updates
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