NDASUBLINGUALTABLET
Approved
Mar 2009
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
3
Data completeness
6/8 — Strong
EDLUAR (zolpidem tartrate) by Viatris (2) is short-term treatment of insomnia through binding to the benzodiazepine site of α 1 subunit containing gaba a receptors, increasing the frequency of chloride channel opening resulting in the inhibition of neuronal excitation. First approved in 2009.
Drug data last refreshed 22h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EDLUAR is a sublingual tablet formulation of zolpidem tartrate, a short-acting sedative-hypnotic approved in 2009 for the short-term treatment of insomnia. It works by binding to benzodiazepine receptors on GABA_A channels, increasing chloride influx and inhibiting neuronal excitation to promote sleep onset. The sublingual route offers rapid absorption and an alternative to oral tablets for patients with swallowing difficulties.
$0.749MPart D
Peak4.7 years to LOEProduct is at peak commercial maturity with stable but modest Medicare utilization; brand teams focus on lifecycle extension and retention against generic competition.
Mechanism of Action
short-term treatment of insomnia through binding to the benzodiazepine site of α 1 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
Why This Matters for Your Career
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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.