Zolpidem Tartrate Zolpidem tartrate 6.25 MG Extended Release Oral Tablet

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 receptor positive modulator, are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. ( 1 )

Par Pharmaceutical, Inc.

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

8 years ago

ROUND YELLOW a117

16 HOW SUPPLIED/STORAGE AND HANDLING Zolpidem Tartrate Extended-Release Tablets, USP, 6.25 mg are available as yellow round film coated tablets engraved with “A117” on one side and plain on the other side. They are supplied as follows: NDC Number Size 10370-117-10 bottle of 100 Zolpidem Tartrate Extended-Release Tablets, USP, 12.5 mg are available as white to off-white round film coated tablets engraved with “A116” on one side and plain on the other side. They are supplied as follows: NDC Number Size 10370-116-10 bottle of 100 Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP controlled room temperature].

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Zolpidem Tartrate Zolpidem tartrate 6.25 MG Extended Release Oral Tablet

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

ROUND YELLOW a117

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