Ambien CR 12.5 mg/1

zolpidem tartrate · TABLET, COATED · Sanofi-Aventis U.S. LLC

No Recall History

Plain English

Ambien CR is a tablet, coated containing zolpidem tartrate at 12.5 mg/1, taken oral. Manufactured by Sanofi-Aventis U.S. LLC.

Key Facts

Brand Name: Ambien CR
Generic Name: zolpidem tartrate
NDC Code (Product): 0024-5521
Manufacturer: Sanofi-Aventis U.S. LLC
Strength: 12.5 mg/1
Dosage Form: TABLET, COATED
Route: ORAL
Marketing Status
DEA Schedule: Schedule IV (Controlled)
Application #: NDA021774
Marketing Start: 09/19/2005

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea6,052 reports

fatigue5,908 reports

drug ineffective5,905 reports

insomnia4,805 reports

pain4,728 reports

headache4,474 reports

diarrhoea4,105 reports

anxiety3,932 reports

dizziness3,780 reports

dyspnoea3,699 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 )

Dosage & Administration

2 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 or 12.5 mg for men, immediately before bedtime with at least 7–8 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 men and women ( 2.2 ) Lower doses of CNS depressants may be necessary when taken concomitantly with AMBIEN CR ( 2.3 ) Tablets to be swallowed whole, not to be crushed, divided or chewed ( 2.4 ) The effect of AMBIEN CR may be slowed if taken with or immediately after a meal ( 2.4 ) 2.1 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…

Contraindications

4 CONTRAINDICATIONS AMBIEN CR is contraindicated in patients who have experienced complex sleep behaviors after taking AMBIEN CR [see Warnings and Precautions (5.1) ]. with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.4) ]. Patients who have experienced complex sleep behaviors after taking AMBIEN CR ( 4 ) Known hypersensitivity to zolpidem ( 4 )

Drug Interactions

7 DRUG INTERACTIONS CNS depressants, including alcohol: Possible adverse additive CNS-depressant effects ( 5.2 , 7.1 ) Opioids: Concomitant use may increase risk of respiratory depression ( 5.7 , 7.1 ) Imipramine: Decreased alertness observed ( 7.1 ) Chlorpromazine: Impaired alertness and psychomotor performance observed ( 7.1 ) CYP3A4 inducers (rifampin or St. John's wort): Combination use may decrease effect ( 7.2 ) Ketoconazole: Combination use may increase effect ( 7.2 ) 7.1 CNS-Active Drugs CNS Depressants Coadministration of zolpidem with other CNS depressants increases the risk of CNS depression. Concomitant use of zolpidem with these drugs may increase drowsiness and psychomotor impairment, including impaired driving ability [see Warnings and Precautions (5.1 , 5.2) ]. Zolpidem tartrate was evaluated in healthy volunteers in single-dose interaction studies for several CNS drugs. Alcohol An additive adverse effect on psychomotor performance between alcohol and oral zolpidem was demonstrated [see Warnings and Precautions (5.1 , 5.2) ] . Opioids The concomitant use of AMBIEN CR with opioids may increase the risk of respiratory depression. Limit dosage and duration of concomita…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Complex Sleep Behaviors [see Warnings and Precautions (5.1) ] CNS-Depressant Effects and Next-Day Impairment [see Warnings and Precautions (5.2) ] Severe Anaphylactic and Anaphylactoid Reactions [see Warnings and Precautions (5.4) ] Abnormal Thinking and Behavior Changes [see Warnings and Precautions (5.5) ] Withdrawal Effects [see Warnings and Precautions (5.9) ] Most commonly observed adverse reactions (>10% in either elderly or adult patients) are: headache, next-day somnolence and dizziness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Associated with Discontinuation of Treatment In 3-week clinical trials in adults and elderly patients (>65 years), 3.5% (7/201) patients receiving AMBIEN CR 6.25 or 12.5 mg discontinued treatment due to an adverse reaction as compared to 0.9% (2/216) of patients on placebo. The reaction most commonly associated with discontinuation in patients treated with AMBIEN CR was somnolence (1%).…

Frequently Asked Questions

What is Ambien CR used for?

Ambien CR contains zolpidem tartrate. It is a tablet, coated taken oral. Consult your doctor for specific uses.

Is Ambien CR a controlled substance?

Yes, Ambien CR is classified as CIV under the DEA Controlled Substances Act.

What is the generic name for Ambien CR?

The generic name for Ambien CR is zolpidem tartrate. There are 12 other brand versions of zolpidem tartrate.

What is the NDC code for Ambien CR 12.5 mg/1?

The NDC (National Drug Code) for Ambien CR 12.5 mg/1 is 0024-5521, listed by Sanofi-Aventis U.S. LLC.

Product NDC

0024-5521

Package NDC

0024-5521-31

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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