zolpidem tartrate extendedrelease zolpidem tartrate tablet film coated extended release

1 INDICATIONS AND USAGE Zolpidem Tartrate Extended-Release Tablets, USP, 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 ) ] . Zolpidem tartrate extended-release tablets, a gamma-aminobutyric acid (GABA) A agonist are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. ( 1 )

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FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] toxicity to various agents` `[3] completed suicide` `[4] fatigue` `[5] nausea` `[6] drug abuse` `[7] off label use` `[8] pain` `[9] headache` `[10] dizziness`

6 years ago

ROUND WHITE A116

16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50436-0116

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zolpidem tartrate extendedrelease zolpidem tartrate tablet film coated extended release

FDA Reported Adverse Reactions [1] drug ineffective [2] toxicity to various agents [3] completed suicide [4] fatigue [5] nausea [6] drug abuse [7] off label use [8] pain [9] headache [10] dizziness

ROUND WHITE A116

More pills like ROUND A116

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] toxicity to various agents` `[3] completed suicide` `[4] fatigue` `[5] nausea` `[6] drug abuse` `[7] off label use` `[8] pain` `[9] headache` `[10] dizziness`