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Zolpidem Tartrate (Zolpidem Tartrate)

Trade Name : Zolpidem Tartrate

NorthStar Rx LLC

TABLET, FILM COATED

Strength 5 mg/1

ZOLPIDEM TARTRATE gamma-Aminobutyric Acid-ergic Agonist [EPC],GABA A Agonists [MoA],Pyridines [CS],Central Nervous System Depression [PE]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Zolpidem Tartrate (Zolpidem Tartrate) which is also known as Zolpidem Tartrate and Manufactured by NorthStar Rx LLC. It is available in strength of 5 mg/1 per ml. Read more

Zolpidem Tartrate (Zolpidem Tartrate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Boxed Warningu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a008/2019
  • Contraindications ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a008/2019
  • Warnings and Precautions, Complex Sleep Behaviors ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a008/2019
  • Warnings and Precautions, CNS-Depressant Effects and
  • Next-Day Impairment ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a002/2019
  • Complex sleep behaviors including sleep-walking, sleep-driving,u00a0 engaging in other activities while not fully awake may occur following use of zolpidem tartrate. Some of these events may result in serious injuries, including death. Discontinue zolpidem tartrate immediately if a patient experiences a complex sleep behavior n
  • WARNING: COMPLEX SLEEP BEHAVIORS
  • See full prescribing information for complete boxed warning.
  • Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of zolpidem tartrate. Some of these events may result in serious injuries, including death. Discontinue zolpidem tartrate immediately if a patient experiences a complex sleep behavior (4, 5.1).
  • 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 .n The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
  • Zolpidem tartrate tablets, u00a0a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. ()
  • No data
  • Use the lowest dose effective for the patient and must not exceed a total ofu00a0 10 mg dailyu00a0n
  • 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 to 8 hours remaining before the planned time of awakeningu00a0n
  • Geriatric patients and patients with mild to moderate hepatic impairment: Recommended dose is 5 mg for men and women n
  • Lower doses of CNS depressants may be necessary when taken concomitantly with zolpidem tartrate tablets (n
  • The effect of zolpidem tartrate tablets may be slowed if taken with or immediately after a meal n
  • Zolpidem tartrate is available in 5 mg and 10 mg strength tablets for oral administration. Tablets are not scored.n Zolpidem tartrate tablets USP 5 mg are white to off-white, circular, biconvex, film-coated tablets, debossed with u201cEu201d on one side and u201c78u201d on the other side.n Zolpidem tartrate tablets USP 10 mg are white to off-white, oval shaped, biconvex, film-coated tablets, debossed with u201cEu201d on one side and u201c79u201d on the other side.
  • 5 mg and 10 mg tablets. Tablets scored. u00a0
  • Zolpidem tartrate tablets are contraindicated in patients
  • Patients who have experienced complex sleep behaviors after taking zolpidem tartrate tablets ()
  • Known hypersensitivity to zolpidem ()
  • No data
  • CNS-Depressant Effects: Impairs alertness and motor coordination including risk of morning impairment. Risk increases with dose and use with other CNS depressants and alcohol. Instruct patients on correct use. ()
  • Need to Evaluate for Comorbid Diagnoses: Re-evaluate if insomnia persists after 7 to 10 days of use. ()
  • Severe Anaphylactic/Anaphylactoid Reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur. ()
  • Abnormal Thinking and Behavioral Changes: Changes including decreased inhibition, bizarre behavior, agitation, and depersonalization have been reported. Immediately evaluate any new onset behavioral changes. ()
  • Depression: Worsening of depression or suicidal thinking may occur. Prescribe the least amount of tablets feasible to avoid intentional overdose. ()
  • Respiratory Depression: Consider this risk before prescribing in patients with compromised respiratory function. ()
  • Hepatic Impairment: Avoid zolpidem tartrate use in patients with severe hepatic impairment. ()
  • Withdrawal Effects: Symptoms may occur with rapid dose reduction or discontinuation. (, )
  • The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
  • Most commonly observed adverse reactions were:u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Short-term (<10 nights): Drowsiness, dizziness, and diarrheau00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Long-term (28 to 35 nights): Dizziness and drugged feelings n n
  • No data
  • CNS depressants, including alcohol: Possible adverse additive CNS-depressant effects (, n
  • Imipramine: Decreased alertness observedu00a0n
  • Chlorpromazine: Impaired alertness and psychomotor performance observed n
  • CYP3A4 inducers (rifampin or St. John's wort): Combination use may decrease effect n
  • Ketoconazole: Combination use may increase effect n
  • No data
  • Pregnancy: May cause respiratory depression and sedation in neonates with exposure late in the third trimester. ()
  • Lactation: A lactating woman may pump and discard breast milk during treatment and for 23 hours after zolpidem tartrate administration. ()
  • Pediatric use: Safety and effectiveness not established. Hallucinations (incidence rate 7%) and other psychiatric and/or nervous system adverse reactions were observed frequently in a study of pediatric patients with Attention-Deficit/Hyperactivity Disorder. (, )u00a0
  • No data
  • No data
  • Zolpidem tartrate USP is a gamma-aminobutyric acid (GABA) Au00a0receptor positive modulatoru00a0of the imidazopyridine class. Zolpidem tartrate USPu00a0is available in 5 mg and 10 mg strength tablets for oral administration.n 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 USP 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.n Each zolpidem tartrate tablet, USPu00a0includes the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide.n Meets USP Dissolution Test-3.
  • No data
  • Carcinogenesis
  • Zolpidem was administered to mice and rats for 2 years at oral doses of 4, 18, and 80 mg base/kg/day. In mice, these doses are approximately 2.5, 10, and 50 times the MRHD of 10 mg/day (8 mg zolpidem base) based on mg/mbody surface area and in rats, these doses are approximately 5, 20, and 100 times the MRHD based on mg/mbody surface area. No evidence of carcinogenic potential was observed in mice. In rats, renal tumors (lipoma, liposarcoma) were seen at the mid and high doses.
  • Mutagenesis
  • Zolpidem was negative in (bacterial reverse mutation, mouse lymphoma, and chromosomal aberration) and (mouse micronucleus) genetic toxicology assays.
  • Impairment of Fertility
  • Zolpidem was administered to rats at 4, 20, and 100 mg base/kg/day, which are approximately 5, 25, and 120 times the MRHD of 10 mg/day (8 mg zolpidem base) based on mg/m body surface area, prior to and during mating, and continuing in females through postpartum day 25. Zolpidem caused irregular estrus cycles and prolonged precoital intervals at the highest dose tested, which is approximately 120 times the MRHD based on mg/m body surface area. The NOAEL for these effects is 25 times the MRHD based on a mg/m body surface area. There was no impairment of fertility at any dose tested.
  • No data
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Inform patients and their families about the benefits and risks of treatment with zolpidem tartrate. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with zolpidem tartrate and with each prescription refill. Review the zolpidem tartrate Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that zolpidem tartrate should be taken only as prescribed.
  • Complex Sleep Behaviorsn n- [see , ].n n- Arrayn- [see ]n- Severe Anaphylactic and Anaphylactoid Reactions
  • u00a0u00a0
  • Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with zolpidem. Describe the signs/symptoms of these reactions and advise patients to seek medical attention immediately if any of them occur .
  • Suicide
  • u00a0u00a0
  • Tell patients to immediately report any suicidal thoughts.
  • u00a0
  • Alcohol and other Drugs
  • u00a0u00a0
  • Ask patients about alcohol consumption, medicines they are taking, and drugs they may be taking without a prescription. Advise patients not to use zolpidem tartrate if they drank alcohol that evening or before bed.
  • Tolerance, Abuse, and Dependence
  • u00a0u00a0
  • Tell patients not to increase the dose of zolpidem tartrate on their own, and to inform you if they believe the drug u201cdoes not work.u201d
  • Administration Instructionsn
  • u00a0u00a0
  • Patients should be counseled to take zolpidem tartrate right before they get into bed and only when they are able to stay in bed a full night (7 to 8 hours) before being active again. Zolpidem tartrate tablets should not be taken with or immediately after a meal. Advise patients NOT to take zolpidem tartrate if they drank alcohol that evening.
  • Pregnancy
  • Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with zolpidem tartrate. Advise patients that use of zolpidem tartrate late in the third trimester may cause respiratory depression and sedation in neonates. Advise mothers who used zolpidem tartrate during the late third trimester of pregnancy to monitor neonates for signs of sleepiness (more than usual), breathing difficulties, or limpness n
  • u00a0u00a0
  • Lactation
  • Advise breastfeeding mothers using zolpidem tartrate to monitor infants for increased sleepiness, breathing difficulties, or limpness. Instruct breastfeeding mothers to seek immediate medical care if they notice these signs. A lactating woman may consider pumping and discarding breastmilk during treatment and for 23 hours after zolpidem tartrate administration to minimize drug exposure to a breastfed infant .
  • Medication Guides available at or call 1-800-206-7821.
  • Zolpidem Tartrate Tablets, USP C-IVn (zol' pi dem tar' trate)n
  • Arrayn- Array
  • Zolpidem tartrate may cause serious side effects, including:
  • Arrayn- Array
  • Do not take zolpidem tartrate if you:
  • What is zolpidem tartrate?n
  • R only NDC 16714-621-01 Zolpidem Tartrate Tablets, USP 5 mg CIV PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY. 100 Tablets Northstar R LLCn n n n
  • R only NDC 16714-622-01 Zolpidem Tartrate Tablets, USP 10 mg CIV PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE PROVIDED SEPARATELY. 100 Tablets Northstar R LLCn n n n n

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