1 INDICATIONS AND USAGE
id: 3407DEA2-8843-8B8F-DFE9-AFF3FF9B2711
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: 7C465822-2E45-A2B5-74EF-DC79B76EF3F5
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 white round film-coated tablets engraved with “CST 8”. Zolpidem tartrate tablets 10-mg are white round film-coated tablets engraved with “B”. Tablets are not scored.
6 ADVERSE REACTIONS
id: B3D824C2-69AF-4C03-9369-27074E3BBF42
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: 1179EEA5-AD46-F594-EB53-93DAEEFFF6C0
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: lactose, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide.
