NDAORALCAPSULE
Approved
May 2023
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
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. Approved for insomnia. First approved in 2023.
Drug data last refreshed 1w ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Zolpidem tartrate is a short-acting sedative-hypnotic small molecule approved in May 2023 for the 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. The newly approved capsule formulation from Almatica Pharma enters a mature, competitive market dominated by generic versions and newer mechanism agents.
Growth
Early-stage growth product entering a crowded market; commercial team is likely building post-launch awareness and payer relationships.
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 (1)
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
Worked on ZOLPIDEM TARTRATE at Almatica Pharma? Share your interview experience or compensation data (+7 days Pro)
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.