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zolpidem

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

zolpidem: sourced relationships with 3 companies · 3 FDA decisions.

zolpidem evidence translation

What we can confirm

3 FDA records

What it means

More than one company relationship 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

Dated Pipeline Records (4)
CompanyDated record stage
AYTU BIOPHARMA, INC (AYTU)
Reported 2008-12-19 · Current development: unknownSource
Approved
Teva Pharmaceutical Industries Limited (TEVA)
Reported 2007-04-23 · Current development: unknownSource
Approved
Viatris Inc (VTRS)
Reported 2009-03-13 · Current development: unknownSource
Approved
Viatris Inc (VTRS)
Reported 2009-03-13 · Current development: unknownSource
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 treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate has been shown to decrease sleep latency for up to 35 days in controlled clinical studies. ( 1 )(VTRS)FDA ↗
NDA021997Type 3 - New Dosage FormStandardOtherTablet
Approval(AYTU)FDA ↗
NDA022196Type 3 - New Dosage FormStandardOralSpray, Metered
Approval(TEVA)FDA ↗
ANDA076410OralTablet

Frequently asked questions

Which companies have sourced relationships with zolpidem?

zolpidem has dated SEC/FDA relationship records for 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 treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate has been shown to decrease sleep latency for up to 35 days in controlled clinical studies. ( 1 ), dated March 13, 2009.