NDAORALTABLET, EXTENDED RELEASE
Approved
Sep 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
5/8 — Partial
AMBIEN CR (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 2005.
Drug data last refreshed 6h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Ambien CR is an extended-release formulation of zolpidem tartrate, a non-benzodiazepine hypnotic approved for short-term treatment of insomnia. It works by binding to benzodiazepine receptors on GABA-A channels, increasing chloride channel opening and inhibiting neuronal excitation to promote sleep initiation and maintenance. The extended-release mechanism delivers immediate and delayed drug release to address both sleep onset and sleep maintenance.
$6.0MPart D
LOE ApproachingAs LOE approaches, the brand team is likely rightsizing and shifting focus toward managed decline and generic transition planning.
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 (5)
Ambien CR vs. Placebo For Treatment Of Insomnia Associated With Anxiety When Used Concomitantly With Escitalopram (Lexapro)
Started Feb 2006
372 enrolled
Insomnia
Ambien CR For Treatment Of Insomnia Associated With Depression When Used Concomitantly With Lexapro
Started Feb 2006
372 enrolled
Insomnia
Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo
Started Jan 2006
36 enrolled
Insomnia
Zolpidem Tartrate 10 mg Tablets Under Non-Fasting Conditions
Started Mar 2002
24 enrolled
Healthy
Zolpidem Tartrate 10 mg Tablets Under Fasting Conditions
Started Feb 2002
38 enrolled
Healthy
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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.