ZOLPIDEM TARTRATE 5 mg/1
zolpidem tartrate · TABLET · Quality Care Products LLC
ZOLPIDEM TARTRATE is a tablet containing zolpidem tartrate at 5 mg/1, taken oral. Manufactured by Quality Care Products LLC.
Key Facts
- Brand Name
- ZOLPIDEM TARTRATE
- Generic Name
- zolpidem tartrate
- NDC Code (Product)
55700-268- Manufacturer
- Quality Care Products LLC
- Strength
- 5 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA077903
- Marketing Start
- 09/05/2007
Recall History
Aurobindo Pharma LTD
Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg
SUN PHARMACEUTICAL INDUSTRIES INC
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Wockhardt Usa Inc.
CGMP Deviations: Firm did not adequately investigate customer complaints.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
American Health Packaging
Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.
Wockhardt Usa Inc.
CGMP Deviations: Firm did not adequately investigate customer complaints.
SUN PHARMACEUTICAL INDUSTRIES INC
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Purdue Pharma L.P.
Failed dissolution specifications
Purdue Pharma L.P.
Failed Dissolution Specifications
Aidapak Services, LLC
Labeling: Label Mixup; ZOLPIDEM TARTRATE Tablet, 2.5 mg (1/2 of 5 mg) may be potentially mislabeled as TEMAZEPAM, Capsule, 7.5 mg, NDC 00378311001, Pedigree: AD22861_7, EXP: 5/8/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Zolpidem tartrate extended-release tablets 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 extended-release tablet, 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 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 men and women ( 2.2 ) Lower doses of CNS depressants may be necessary when taken concomitantly with zolpidem tartrate extended-release tablets ( 2.3 ) Tablets to be swallowed whole, not to be crushed, divided or chewed ( 2.4 ) The effect of zolpidem tartrate extended-release tablets 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 to 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…
Contraindications
4 CONTRAINDICATIONS • Patients who have experienced complex sleep behaviors after taking zolpidem tartrate extended-release tablets ( 4 ) • Known hypersensitivity to zolpidem ( 4 ) Zolpidem tartrate extended-release tablets are contraindicated in patients who have experienced complex sleep behaviors after taking zolpidem tartrate extended-release tablets [see WARNINGS AND PRECAUTIONS ( 5.1 )]. with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see WARNINGS AND PRECAUTIONS ( 5.4 )].
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 zolpidem tartrate extended-release tablets with opioids may increase the risk of respiratory depression. Limi…
Adverse Reactions
6 ADVERSE REACTIONS 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 Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 )] 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 zolpidem tartrate extended-release tablets 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 treat…
Frequently Asked Questions
What is ZOLPIDEM TARTRATE used for?
ZOLPIDEM TARTRATE contains zolpidem tartrate. It is a tablet taken oral. Consult your doctor for specific uses.
Is ZOLPIDEM TARTRATE a controlled substance?
Yes, ZOLPIDEM TARTRATE is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for ZOLPIDEM TARTRATE?
The generic name for ZOLPIDEM TARTRATE is zolpidem tartrate. There are 8 other brand versions of zolpidem tartrate.
What is the NDC code for ZOLPIDEM TARTRATE 5 mg/1?
The NDC (National Drug Code) for ZOLPIDEM TARTRATE 5 mg/1 is 55700-268, listed by Quality Care Products LLC.