NDAORALTABLET
Approved
Dec 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
5/8 — Partial
AMBIEN (zolpidem tartrate) by Almatica Pharma is short-term treatment of insomnia through binding to the benzodiazepine site of α1 subunit containing gaba a receptors, increasing the frequency of chloride channel opening resulting in the inhibition of neuronal excitation. First approved in 1992.
Drug data last refreshed 2h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMBIEN (zolpidem tartrate) is a short-acting sedative-hypnotic that treats insomnia by binding to benzodiazepine receptors on GABA-A channels, increasing chloride channel opening and suppressing neuronal excitation. Administered orally as a tablet, it has been a standard first-line therapy for sleep initiation since its 1992 approval. The drug is indicated for short-term insomnia treatment in adults.
$12MPart D
LOE ApproachingDeclining
LOE-approaching status signals consolidation within the brand team and potential restructuring as generic competition intensifies.
Mechanism of Action
short-term treatment of insomnia through binding to the benzodiazepine site of α1 subunit containing GABA A receptors, increasing the frequency of chloride channel opening resulting in the inhibition of neuronal excitation.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (13)
A Randomized Controlled Trial of Ambient Artificial Intelligence Scribe Technologies
Started Nov 2024
238 enrolled
Physician WorkflowArtificial Intelligence (AI)
Health Effects of Repeated Exposure to Low Levels of Concentrated Ambient Particles in Healthy Young Volunteers
Started May 2022
20 enrolled
Air Pollution
Astigmatism Correction With Intrastromal Arcuate Incisions in Eyes Undergoing Cataract Surgery With Femtosecond Laser Using the Cassini Ambient With Iris Registration (ARCUATAS)
Started Oct 2021
22 enrolled
CataractAstigmatism
Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage
Started Nov 2016
174 enrolled
Trypanosomiasis, AfricanSleeping SicknessTrypanosomiasis; Gambian
Effects of Omega-3 Fatty Acids in Ambient Air Pollution Exposure in Healthy Adults
Started Sep 2016
62 enrolled
Health Effects of Ambient Air Pollution
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.