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zolpidem

Generic: ZOLPIDEM TARTRATE·Brand: AMBIEN, AMBIEN CR, EDLUAR, Edluar, INTERMEZZO, TOVALT ODT, ZOLPIDEM TARTRATE, ZOLPIMIST, Zolpimist

zolpidem: developed by 3 companies · 3 FDA decisions.

zolpidem evidence translation

What we can confirm

3 FDA records

What it means

More than one developer is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch for new trials or company disclosures after the FDA record.
BioSniper AIPage evidence connected

Prepared research question

What is verified about zolpidem, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

Development Pipeline (4)
CompanyPhase
AYTU BIOPHARMA, INC (AYTU)Approved
Teva Pharmaceutical Industries Limited (TEVA)Approved
Viatris Inc (VTRS)Approved
Viatris Inc (VTRS)Approved
FDA Decisions3 records
Approval1 INDICATIONS AND USAGE Edluar (zolpidem tartrate) sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation [see Clinical Studies (14) ] . The clinical trials performed with zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Edluar, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term(VTRS)FDA ↗
NDA021997Type 3 - New Dosage FormStandardOtherTablet
Approval(AYTU)FDA ↗
NDA022196Type 3 - New Dosage FormStandardOralSpray, Metered
Approval1 INDICATIONS AND USAGE Zolpidem Tartrate Tablets USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets USP have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [ see Clinical Studies ( 14 ) ]. The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem Tartra(TEVA)FDA ↗
ANDA076410OralTablet

Frequently asked questions

Who is developing zolpidem?

zolpidem is being developed by AYTU BIOPHARMA, INC, Teva Pharmaceutical Industries Limited, Viatris Inc.

What is zolpidem's latest FDA decision?

The most recent tracked FDA decision for zolpidem is Approval for 1 INDICATIONS AND USAGE Edluar (zolpidem tartrate) sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation [see Clinical Studies (14) ] . The clinical trials performed with zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Edluar, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term, dated March 13, 2009.