zolpidem tartrate 12.5 MG Extended Release Oral Tablet Ambien

1 INDICATIONS AND USAGE AMBIEN CR (zolpidem tartrate extended-release tablets) is 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) ] . AMBIEN CR, 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 )

sanofi-aventis u.s. llc

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

2 years ago

ROUND BLUE A

16 HOW SUPPLIED/STORAGE AND HANDLING AMBIEN CR 6.25 mg extended-release tablets are composed of two layers Layers are covered by the coating and are indistinguishable. and are coated, pink, round, biconvex, debossed with A~ on one side and supplied as: NDC Number Size 0024-5501-31 bottle of 100 AMBIEN CR 12.5 mg extended-release tablets are composed of two layers and are coated, blue, round, biconvex, debossed with A~ on one side and supplied as: NDC Number Size 0024-5521-31 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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