NDAORALSPRAY, METERED
Approved
Dec 2008
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
3
Data completeness
4/8 — Partial
ZOLPIMIST (zolpidem tartrate) by Aytu BioPharma 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 2008.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZOLPIMIST is a metered-dose oral spray formulation of zolpidem tartrate, a non-benzodiazepine hypnotic, approved for 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 to promote sleep. The spray formulation offers an alternative delivery route to traditional tablets.
Peak6.1 years to LOE
Peak lifecycle stage with no linked open positions suggests mature product with stable but likely limited team expansion opportunities.
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
ZOLPIMIST currently shows zero linked job openings, reflecting its peak-stage maturity and small commercial footprint under Aytu BioPharma. Careers in this product are best suited for those seeking stability in a niche hypnotic segment rather than growth or innovation opportunities.
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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.