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

PK/PD Study of YZJ-1139

Phase 1

Completed

Conditions: Insomnia

Interventions: Drug: YZJ-1139
Drug: Placebo
Drug: Zolpidem

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

Recruiting

Conditions: Sleep Disorder

Interventions: Drug: Zolpidem
Drug: Pregabalin

First Posted Date: 2024-07-22

Last Posted Date: 2024-11-13

Lead Sponsor: Mengchang Yang

Target Recruit Count: 222

Registration Number: NCT06512155

Locations: 🇨🇳
Sichuan Provincial People's Hospita, Chengdu, Sichuan, China

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
Drug: Zolpidem

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
Drug: Zolpidem

First Posted Date: 2023-10-16

Last Posted Date: 2023-10-16

Lead Sponsor: Siriraj Hospital

Target Recruit Count: 30

Registration Number: NCT06084130

Intranasal Dexmedetomidine and Zolpidem for Treatment of Primary Insomnia

Phase 3

Recruiting

Conditions: Insomnia

Interventions: Drug: Zolpidem
Drug: Dexmedetomidine
Other: Placebo

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: Zolpidem
Drug: Placebo

First Posted Date: 2022-09-14

Last Posted Date: 2024-12-16

Lead Sponsor: Stanford University

Target Recruit Count: 26

Registration Number: NCT05540574

Locations: 🇺🇸
Stanford University, Stanford, California, United States

A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem

Phase 1

Completed

Conditions: Healthy Non-dependent, Recreational Sedative Users
Abuse Potential

Interventions: Drug: Suvorexant
Drug: Zolpidem
Drug: Placebo
Drug: Seltorexant

First Posted Date: 2021-11-03

Last Posted Date: 2024-06-21

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 127

Registration Number: NCT05106153

Locations: 🇺🇸
Altasciences Inc., Overland Park, Kansas, United States

Sleep and Breathing in the General Population - Chemical Stimuli

Phase 4

Completed

Conditions: Sleep-disordered Breathing

Interventions: Drug: Zolpidem
Other: No Treatment

First Posted Date: 2021-01-22

Last Posted Date: 2023-12-06

Lead Sponsor: Wayne State University

Target Recruit Count: 14

Registration Number: NCT04720547

Locations: 🇺🇸
John D. Dingell VA Medical Center, Detroit, Michigan, United States

Electrophysiological and Neuroimaging Correlates of the Effect of Zolpidem in Patients With Focal Dystonia

Phase 1

Completed

Conditions: Focal Dystonia

Interventions: Drug: Placebo
Drug: Zolpidem

First Posted Date: 2020-12-31

Last Posted Date: 2023-12-04

Lead Sponsor: University Medical Centre Ljubljana

Target Recruit Count: 24

Registration Number: NCT04692285

Locations: 🇸🇮
Departmet of Neurology, University Medical Centre Ljubljana, Ljubljana, Slovenia
🇷🇸
University Clinical Centre of Serbia, Belgrade, Serbia

CBT-I or Zolpidem/Trazodone for Insomnia

Phase 4

Completed

Conditions: Chronic Insomnia

Interventions: Behavioral: Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)
Drug: Zolpidem
Drug: Trazodone

First Posted Date: 2020-07-13

Last Posted Date: 2024-07-19

Lead Sponsor: California Pacific Medical Center Research Institute

Target Recruit Count: 155

Registration Number: NCT04468776

Locations: 🇺🇸
University of Missouri, Columbia, Missouri, United States
🇺🇸
Penn State Hershey Medical Center, Hershey, Pennsylvania, United States
🇺🇸
University of Virginia, Charlottesville, Virginia, United States

and more 4 locations

Drug Development Updates

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