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Zolpidem Tartrate

Zolpidem Tartrate is one of 8,063 medications in the MedPlain dataset. Key details — Brand name: Zolpidem Tartrate; Generic name: ZOLPIDEM TARTRATE; Manufacturer: Sun Pharmaceutical Industries, Inc..

Brand nameZolpidem Tartrate
Generic nameZOLPIDEM TARTRATE
ManufacturerSun Pharmaceutical Industries, Inc.
Used for1 INDICATIONS AND USAGE Zolpidem tartrate extended-release tablets, USP 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, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep onse
Dosage2 DOSAGE AND ADMINISTRATION Use the lowest dose effective for the patient and must not exceed a total of 12.5 mg daily ( 2.1 ) Treatment should be as short as possible (2.1) Recommended initial dose is a single dose of 6.25 mg for women and a single dose of 6.25 mg or 12.5 mg for men, immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening ( 2.1 ) Geriatric patients and patients with mild to moderate hepatic impairment: Recommended dose is 6.25 mg for
WarningsWARNING: COMPLEX SLEEP BEHAVIORS Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of zolpidem tartrate extended-release tablets. Some of these events may result in serious injuries, including death. Discontinue zolpidem tartrate extended-release tablets immediately if a patient experiences a complex sleep behavior [see Contraindications (4) and Warnings and Precautions (5.1)]. WARNING: COMPLEX SLEEP BEH
Active ingredient(s)ZOLPIDEM TARTRATE
RouteORAL
Official labelhttps://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0c64bc71-2e7f-4b15-a8e1-acb8de04395f

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