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

Safety and Efficacy Study of YZJ-1139 Tablets in Insomnia Disorder

Phase 3
Recruiting
Conditions
Insomnia Disorder
Interventions
First Posted Date
2025-05-16
Last Posted Date
2025-05-16
Lead Sponsor
Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Target Recruit Count
60
Registration Number
NCT06975514
Locations
🇨🇳

Beijing HuiLongGuan Hospital, Beijing, China

🇨🇳

Peking University People's Hospital, Beijing, China

🇨🇳

ChengDu Second People's Hospital, Chengdu, China

and more 14 locations

Zolpidem's Effects on Road Cycling Performance

Phase 4
Completed
Conditions
Healthy
Interventions
Other: Placebo
First Posted Date
2025-01-30
Last Posted Date
2025-01-30
Lead Sponsor
National Taiwan Normal University
Target Recruit Count
15
Registration Number
NCT06800378
Locations
🇨🇳

Ten-Chan General hospital, Taoyuan, Taiwan

PK/PD Study of YZJ-1139

Phase 1
Completed
Conditions
Insomnia
Interventions
First Posted Date
2024-11-12
Last Posted Date
2024-11-12
Lead Sponsor
Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
Target Recruit Count
20
Registration Number
NCT06685341
Locations
🇨🇳

Beijing Tiantan Hospital, Capital Medical University, Beijing, China

Improving Perioperative Sleep Disorders

Phase 1
Completed
Conditions
Sleep Disorder
Interventions
First Posted Date
2024-07-22
Last Posted Date
2024-12-30
Lead Sponsor
Mengchang Yang
Target Recruit Count
215
Registration Number
NCT06512155
Locations
🇨🇳

Sichuan Provincial People's Hospita, Chengdu, Sichuan, China

Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial

Phase 4
Not yet recruiting
Conditions
Depressive Disorder, Major
Interventions
First Posted Date
2024-03-12
Last Posted Date
2024-03-12
Lead Sponsor
Sultan Qaboos University
Target Recruit Count
90
Registration Number
NCT06303076

Chinese Medicine Treatment of Adolescent Sleep Disorders and Sleeping Pills Withdrawal

Not Applicable
Recruiting
Conditions
Traditional Chinese Medicine
Sleep Disorder
Interventions
Drug: Suanzaoren Decoction and Huanglian Wendan Decoction
First Posted Date
2024-02-06
Last Posted Date
2024-02-06
Lead Sponsor
The First Affiliated Hospital with Nanjing Medical University
Target Recruit Count
106
Registration Number
NCT06244277
Locations
🇨🇳

The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

Zolpidem on CPAP Acclimatization in OSA

Phase 4
Not yet recruiting
Conditions
Obstructive Sleep Apnea
Interventions
Drug: Placebo
First Posted Date
2023-10-16
Last Posted Date
2023-10-16
Lead Sponsor
Siriraj Hospital
Target Recruit Count
30
Registration Number
NCT06084130

The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

Phase 4
Recruiting
Conditions
Spine Fusion
Lumbar Spine Degeneration
Pain, Postoperative
Lumbar Spine Spondylosis
Interventions
First Posted Date
2023-02-27
Last Posted Date
2024-06-25
Lead Sponsor
University of Southern California
Target Recruit Count
140
Registration Number
NCT05746143
Locations
🇺🇸

Keck Medical Center of USC, Los Angeles, California, United States

Intranasal Dexmedetomidine and Zolpidem for Treatment of Primary Insomnia

Phase 3
Recruiting
Conditions
Insomnia
Interventions
First Posted Date
2022-11-14
Last Posted Date
2022-11-14
Lead Sponsor
The University of Hong Kong
Target Recruit Count
20
Registration Number
NCT05615727
Locations
🇨🇳

HKU Li Ka Shing Faculty of Medicine, Hong Kong, Guangdong, China

Trial of Zolpidem for Sleep in Children With Autism

Phase 2
Recruiting
Conditions
Autism Spectrum Disorder
Autism
Interventions
Drug: Placebo
First Posted Date
2022-09-14
Last Posted Date
2025-02-12
Lead Sponsor
Stanford University
Target Recruit Count
26
Registration Number
NCT05540574
Locations
🇺🇸

Stanford University, Stanford, California, United States

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