NDAORALCAPSULE
Approved
May 2023
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
3/8 — Basic
ZOLPIDEM TARTRATE (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 2023.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Zolpidem Tartrate is a short-acting sedative-hypnotic agent approved in May 2023 for the short-term treatment of insomnia. It works by binding to the benzodiazepine site of α1 subunit-containing GABA A receptors, increasing chloride channel opening and inhibiting neuronal excitation. The product is an oral capsule formulation marketed by Almatica Pharma.
Growth
Recent approval positions this product in growth phase with moderate competitive intensity (30% pressure), creating early-stage team-building opportunities in commercial and medical functions.
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 (3)
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
Career Relevance
Working on Zolpidem Tartrate offers early-career exposure to a newly approved CNS product in a competitive, established market with significant managed care complexity. The growth-phase lifecycle and moderate competitive pressure create demand for commercial strategy, payer engagement, and field promotion, though limited clinical development suggests fewer medical/clinical science openings.
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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.