Ambien
(Zolpidem)ApprovedSmall molecule
Zolpidem is used to help people fall asleep at the beginning of the night. It's a short-term treatment for insomnia that works by slowing brain activity to allow sleep.[2] Ambien is currently approved and in use across 25 indications[4].[1]
Ambien is one of 628 small molecule programs targeting Sleep. It is currently in Approved.
25
Indications
86
Total Trials
3
Active Trials
627
Competitors
7
FDA Applications
NDA/BLA/ANDA regulatory filings
5
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 25 indications
Competition
Competitive Landscape
1399 competitors in Prostate Cancer
#DrugCompanyPhaseTrials
1Ambien
PPurdue Pharma LP
Approved
Novantrone
PfizerPreclinical
Mekinist
NovartisPreclinical
Trexall
Alnylam PharmaceuticalsPreclinical
Viagra
VViatris Specialty LLC
Preclinical
Duragesic
CCephalon
Preclinical
Triptorelin Pamoate
IpsenPreclinical
Ifex
BBaxter Healthcare Corporation
Preclinical
Xylocaine
CCitius Pharmaceuticals, Inc.
Preclinical
Precedex
MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Insomnia22 trials
Show 19 more trials
Sequenced Therapies for Comorbid and Primary Insomnias
Completed·—·N/A·NCT01651442·211 enrolled
CBT-I or Zolpidem/Trazodone for Insomnia
Completed·—·Phase 4·NCT04468776·155 enrolled
Fasting Conditions4 trials
Sleep Disorder4 trials
Chinese Medicine Treatment of Adolescent Sleep Disorders and Sleeping Pills Withdrawal
Unknown status·TThe First Affiliated Hospital with Nanjing Medical University·N/A·NCT06244277·106 enrolled
Show 1 more trial
Z-Drugs for Sleep Disorders in Alzheimer's Disease
Completed·—·Phase 3·NCT03075241·62 enrolled
Sleep4 trials
Abuse Potential4 trials
43 more indications
Memory3 trials
Medication2 trials
Single Dose2 trials
Treatment2 trials
Focal Dystonia1 trial
Dexmedetomidine1 trial
Double-blind1 trial
A Comparison of the Physiological and Behavioral Effects of Suvorexant and Zolpidem in Healthy Volunteers: A Randomized, Double-blind, Placebo Controlled Study
Active, not recruiting·WWalter Reed Army Institute of Research (WRAIR)·Phase 1·NCT04273776·90 enrolled
Hip Fracture1 trial
Orthopedic Trauma1 trial
Parkinson's Disease1 trial
Use of Low-dose Zolpidem in Parkinson's Disease
Completed·—·Phase 2·NCT03621046·28 enrolled
Progressive Supranuclear Palsy1 trial
Cycling1 trial
Zolpidem's Effects on Road Cycling Performance
Completed·—·Phase 4·NCT06800378·15 enrolled
Obstructive Sleep Apnea1 trial
Cognition1 trial
Menstrual Cycle1 trial
PK/PD1 trial
Efficacy1 trial
Pilot Study1 trial
Melatonin1 trial
Postoperative Sleep Disturbance1 trial
Hot flashes1 trial
Estrogen for Treating Depression in Menopausal Women With Hot Flashes and Insomnia
Completed·—·Phase 4·NCT00227942·86 enrolled
Insomnia Disorder1 trial
Prostatic Neoplasms1 trial
Unspecified1 trial
Regulatory
FDA Approval Timeline[5]
Dec 16, 1992
AMBIEN
NDA NDA019908
Sep 2, 2005
AMBIEN CR
NDA NDA021774
Apr 25, 2007
TOVALT ODT
NDA NDA021412
Dec 19, 2008
ZOLPIMIST
NDA NDA022196
Mar 13, 2009
EDLUAR
NDA NDA021997
Nov 23, 2011
INTERMEZZO
NDA NDA022328
May 9, 2023
ZOLPIDEM TARTRATE
NDA NDA215721
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Ambien drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Zolpidem. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]FDA Orange Book — Patent and exclusivity data for Ambien. U.S. Food & Drug Administration.
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- GABA a Receptor Alpha-1/beta-1/gamma-2 Positive Allosteric Modulator[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- PPurdue Pharma LP