Description

  • Generic Name: zolpidem tartrate
  • Brand Name: Ambien CR

AMBIEN CR®
(zolpidem tartrate) Extended-release Tablets

 

DESCRIPTION

AMBIEN CR contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A agonist of the imidazopyridine class. AMBIEN CR (zolpidem tartrate extended-release tablets) is available in 6.25 mg and 12.5 mg strength tablets for oral administration.

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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:

 

AMBIEN CR® (zolpidem tartrate) Structural Formula Illustration

 

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. AMBIEN CR consists of a coated two-layer tablet: one layer that releases its drug content immediately and another layer that allows a slower release of additional drug content. The 6.25 mg AMBIEN CR tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, red ferric oxide, sodium starch glycolate, and titanium dioxide. The 12.5 mg AMBIEN CR tablet contains the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #2, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, sodium starch glycolate, titanium dioxide, and yellow ferric oxide.

INDICATIONS

AMBIEN CR (zolpidem tartrate extended-release tablets) is 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].

DOSAGE AND ADMINISTRATION

Dosage In Adults

Use the lowest effective dose for the patient. The recommended initial dose is 6.25 mg for women and either 6.25 or 12.5 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 6.25 mg dose is not effective, the dose can be increased to 12.5 mg. In some patients, the higher morning blood levels following use of the 12.5 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see WARNINGS AND PRECAUTIONS]. The total dose of AMBIEN CR should not exceed 12.5 mg once daily immediately before bedtime. Ambien CR should be taken as a single dose and should not be readministered during the same night.

The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

Special Populations

Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. The recommended dose of AMBIEN CR in these patients is 6.25 mg once daily immediately before bedtime [see WARNINGS AND PRECAUTIONS, Use in Specific Populations].

Patients with mild to moderate hepatic impairment do not clear the drug as rapidly as normal subjects. The recommended dose of AMBIEN CR in these patients is 6.25 mg once daily immediately before bedtime. Avoid AMBIEN CR use in patients with severe hepatic impairment as it may contribute to encephalopathy [see WARNINGS AND PRECAUTIONS, Use in Specific Populations, CLINICAL PHARMACOLOGY].

Use With CNS Depressants

Dosage adjustment may be necessary when AMBIEN CR is combined with other CNS depressant drugs because of the potentially additive effects [see WARNINGS AND PRECAUTIONS].

Administration

AMBIEN CR extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of AMBIEN CR may be slowed by ingestion with or immediately after a meal.

HOW SUPPLIED

Dosage Forms And Strengths

AMBIEN CR is available as extended-release tablets containing 6.25 mg or 12.5 mg of zolpidem tartrate for oral administration. Tablets are not scored.

AMBIEN CR 6.25 mg tablets are pink, round, bi-convex, and debossed with A~ on one side.

AMBIEN CR 12.5 mg tablets are blue, round, bi-convex, and debossed with A~ on one side.

Storage And Handling

AMBIEN CR 6.25 mg tablets are composed of two layers* and are coated, pink, round, biconvex, debossed with A~ on one side and supplied as:

 

NDC NumberSize
0024-5501-31bottle of 100

 

AMBIEN CR 12.5 mg tablets are composed of two layers* and are coated, blue, round, biconvex, debossed with A~ on one side and supplied as:

 

NDC NumberSize
0024-5521-31bottle of 100
0024-5521-50bottle of 500
0024-5521-10carton of 30 unit dose