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 5h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZOLPIMIST is a metered oral spray formulation of zolpidem tartrate, a short-acting sedative-hypnotic agent approved for short-term treatment of insomnia. It works by binding to benzodiazepine receptors on GABA-A channels, increasing chloride channel opening and reducing neuronal excitation to promote sleep onset. The spray formulation offers an alternative delivery route to traditional tablets.
Peak5.9 years to LOE
Product is at peak lifecycle with mature market penetration; brand teams are likely focused on optimization and retention rather than expansion.
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 offers limited career opportunity signals given zero linked job openings and mature lifecycle status; roles available are primarily in commercial and field execution. Career growth on this product is constrained by market saturation and approaching patent loss, making it better suited for maintenance-focused professionals rather than career advancement seekers.
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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.