1 INDICATIONS AND USAGE
id: 421DE0D1-49C9-8E86-0A25-481BC70BA03C
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)].The clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
3 DOSAGE FORMS AND STRENGTHS
id: 43CB4A67-4E26-DB62-E777-497F7894DE91
displayName: DOSAGE FORMS & STRENGTHS SECTION
FDA Article Code: 43678-2
Zolpidem tartrate tablets are available in 5 mg and 10 mg strength tablets for oral administration.Zolpidem tartrate tablets 5 mg are round, pink, film-coated debossed with MP 724 on one side and plain on the other side. The 10 mg tablets are round, white, film-coated debossed with MP 725 on one side and plain on the other side. Tablets are not scored.
6 ADVERSE REACTIONS
id: 3170D9E2-23DA-AB41-6A1D-C1E5C1FF268E
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
Serious adverse reactions including severe anaphylactic and anaphylactoid reactions, abnormal thinking and behavior, complex behaviors, withdrawal effects, amnesia, anxiety, other neuropsychiatric symptoms and CNS-depressant effects have been reported with zolpidem [see Warnings and Precautions (5)].
11 DESCRIPTION
id: D779EEC5-7A06-1B94-24C9-F3CC2D05392C
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Zolpidem tartrate is a non-benzodiazepine hypnotic of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration.Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure:Zolpidem tartrate is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88.Each zolpidem tartrate tablet includes the following inactive ingredients: carnauba wax, citric acid, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin, and the 5 mg tablet contains iron oxide red.
