Zolpidem 10 mg/1
Zolpidem Tartrate · TABLET · ACI Healthcare USA, Inc
Zolpidem is a tablet containing zolpidem tartrate at 10 mg/1, taken oral. Manufactured by ACI Healthcare USA, Inc.
Key Facts
- Brand Name
- Zolpidem
- Generic Name
- Zolpidem Tartrate
- NDC Code (Product)
71093-156- Manufacturer
- ACI Healthcare USA, Inc
- Strength
- 10 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA077214
- Marketing Start
- 09/24/2020
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 Tablets is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets has 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. Zolpidem Tartrate Tablets, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Use the lowest dose effective for the patient and must not exceed a total of 10 mg daily ( 2.1 ) Treatment should be as short as possible ( 2.1 ) Recommended initial dose is a single dose of 5 mg for women and a single dose of 5 or 10 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 5 mg for men and women ( 2.2 ) Lower doses of CNS depressants may be necessary when taken concomitantly with Zolpidem Tartrate Tablets ( 2.3 ) The effect of Zolpidem Tartrate 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 5 mg for women and either 5 or 10 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 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next-day impairment of driving an…
Contraindications
4 CONTRAINDICATIONS Zolpidem Tartrate Tablets is contraindicated in patients who have experienced complex sleep behaviors after taking Zolpidem Tartrate Tablets [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 Zolpidem Tartrate Tablets ( 4 ) Known hypersensitivity to Zolpidem ( 4 )
Drug Interactions
7 DRUG INTERACTIONS CNS depressants, including alcohol: Possible adverse additive CNS- depressant effects ( 5.1 , 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 Tablets with opioids may increase the risk of respiratory depression. Limit dosage and dura…
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 were: Short-term (<10 nights): Drowsiness, dizziness, and diarrhea Long-term (28-35 nights): Dizziness and drugged feelings ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ACI Healthcare USA, Inc. at 1- 888-802-1213.or www.acihealthcareusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Associated with Discontinuation of Treatment Approximately 4% of 1,701 patients who received Zolpidem at all doses (1.25 to 90 mg) in U.S. premarketing clinical trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from U.S. trials were daytime drowsiness (0.5%),…
Frequently Asked Questions
What is Zolpidem used for?
Zolpidem contains Zolpidem Tartrate. It is a tablet taken oral. Consult your doctor for specific uses.
Is Zolpidem a controlled substance?
Yes, Zolpidem is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Zolpidem?
The generic name for Zolpidem is Zolpidem Tartrate. There are 12 other brand versions of Zolpidem Tartrate.
What is the NDC code for Zolpidem 10 mg/1?
The NDC (National Drug Code) for Zolpidem 10 mg/1 is 71093-156, listed by ACI Healthcare USA, Inc.
Other Zolpidem Brands
See all →- ZOLPIDEM TARTRATE10 mg/172722-104
- ZOLPIDEM TARTRATE12.5 mg/176420-319
- Zolpidem Tartrate10 mg/180425-0059
- Zolpidem Tartrate10 mg/180425-0153
- Zolpidem Tartrate10 mg/180425-0301
- Zolpidem tartrate12.5 mg/10781-5316
- Zolpidem Tartrate10 mg/150090-3878
- ZOLPIDEM TARTRATE5 mg/155154-1398
- Zolpidem Tartrate5 mg/160687-838
- Zolpidem Tartrate10 mg/162135-779
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)