zolpidem tartrate tablet film coated extended release

1 INDICATIONS AND USAGE Zolpidem Tartrate Extended-Release Tablets are indicated for the short-term 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) ] . Zolpidem Tartrate Extended-Release Tablets, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. ( 1 )

aphena pharma solutions - tennessee, llc

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] pain` `[4] nausea` `[5] headache` `[6] dyspnoea` `[7] diarrhoea` `[8] arthralgia` `[9] vomiting` `[10] off label use`

6 years ago

ROUND BLUE ZCR

16 HOW SUPPLIED/STORAGE AND HANDLING

ZOLPIDEM TARTRATE Extended-Release 6.25 mg tablets are composed of two layers Layers are covered by the coating and are indistinguishable. and are coated, pink, round, biconvex, debossed with ZCR on one side and supplied as: NDC Number Size 0955-1702-10 bottle of 100

ZOLPIDEM TARTRATE Extended-Release 12.5 mg tablets are composed of two layers and are coated, blue, round, biconvex, debossed with ZCR on one side and supplied as: NDC Number Size 0955-1703-10 bottle of 100 Store between 15°C–25°C (59°F–77°F). Limited excursions permissible up to 30°C (86°F).

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zolpidem tartrate tablet film coated extended release

FDA Reported Adverse Reactions [1] drug ineffective [2] fatigue [3] pain [4] nausea [5] headache [6] dyspnoea [7] diarrhoea [8] arthralgia [9] vomiting [10] off label use

ROUND BLUE ZCR

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FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] pain` `[4] nausea` `[5] headache` `[6] dyspnoea` `[7] diarrhoea` `[8] arthralgia` `[9] vomiting` `[10] off label use`