Zolpidem Tartrate Extended-release

Zolpidem Tartrate Extended-release

Zolpidem Tartrate Extended-release Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Zolpidem tartrate extended-release tablets are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).

The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see CLINICAL STUDIES (14)].

History

There is currently no drug history available for this drug.

Other Information

Zolpidem Tartrate Extended-Release Tablets contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A agonist of the imidazopyridine class. Zolpidem tartrate extended-release tablets are available in 6.25 mg and 12.5 mg strength tablets for oral administration.

Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure:

molecular-structure.jpg

Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Zolpidem tartrate extended-release tablets are film coated containing a hydrogel-matrix core that provides extended-release of the drug content.

The 6.25 mg zolpidem tartrate extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, D&C yellow #10 aluminum lake, FD&C yellow #6/sunset yellow FCF aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polyvinyl alcohol, sugar, titanium dioxide and talc. The 12.5 mg zolpidem tartrate extended-release tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, polydextrose, polyethylene glycol, sugar, titanium dioxide and triacetin.

USP Dissolution Test Pending

Zolpidem Tartrate Extended-release Manufacturers


  • Par Pharmaceutical, Inc.
    Zolpidem Tartrate Extended-release (Zolpidem Tartrate) Tablet, Film Coated, Extended Release [Par Pharmaceutical, Inc.]

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