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Zolpidem Tartrate (Zolpidem Tartrate)

Trade Name : Zolpidem Tartrate

NCS HealthCare of KY, Inc dba Vangard Labs

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 NCS HealthCare of KY, Inc dba Vangard Labs. 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

Packaging and Delivery

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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.

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About GNH

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
  • Dosage and Administration, Dosage in Adultsu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 08/2016Dosage and Administration, Special Populations ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 12/2016 Warnings and Precautions, CNS Depressant Effects and Next-Day Impairmentu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a008/2016Warnings and Precautions, Precipitation of Hepatic
  • Encephalopathy ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 12/2016
  • 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 .
  • 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, a gamma-aminobutyric acid (GABA) A agonist, are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. n
  • No data
  • Use the lowest dose effective for the patient and must not exceed a total of 10 mg daily n
  • 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 awakening n
  • Geriatric patients and patients with mildu00a0to moderateu00a0hepatic 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 u00a0
  • 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.
  • 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.
  • 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 with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema .
  • Known hypersensitivity to zolpidem n
  • No data
  • CNS depressant effects: Impairs alertness and motor coordination. Instruct patients on correct use. n
  • Need to evaluate for co-morbid diagnoses: Reevaluate if insomnia persists after 7 to 10 days of use.u00a0n
  • Severe anaphylactic/anaphylactoid reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur.u00a0n
  • u201cSleep-drivingu201d and other complex behaviors while not fully awake. Risk increases with dose and use with other CNS depressants and alcohol. Immediately evaluate any new onset behavioral changes. n
  • Depression: Worsening of depression or suicidal thinking may occur. Prescribe the least amount of tablets feasible to avoid intentional overdose.u00a0n
  • Respiratory Depression: Consider this risk before prescribing in patients with compromised respiratory function. n
  • Hepatic Impairment: Avoid zolpidem tartrate tablets use in patients with severe hepatic impairment. ()
  • u00a0Withdrawal effects: Symptoms may occur with rapid dose reduction or discontinuation. (u00a0n
  • Severe Injuries: Drowsiness may leadu00a0to fall including severe injuries. ()
  • 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 u00a0
  • CYP3A4 inducers (rifampin or St. John's wort): Combination use may decrease effect n
  • u00a0Ketoconazole: Combination use may increase effect n
  • No data
  • Pregnancy: Based on animal data, may cause fetal harmu00a0n
  • 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 , n
  • No data
  • No data
  • Zolpidem tartrateu00a0USP is a gamma-aminobutyric acid (GABA) A agonist of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration.
  • 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:n n n
  • Zolpidem tartrateu00a0USP 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.
  • Each zolpidem tartrate tablet, USP includes the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide.
  • Meets USP Dissolution Test-3.
  • No data
  • No data
  • No data
  • Zolpidem Tartrate Tablets USP, 5 mgn- Array
  • Arrayn- Array
  • No data
  • u00a0n- Zolpidem Tartrate Tablets, USP n- CIVn n- (zol' pi dem tar' trate) n n- Arrayn- zolpidem tartrate?
  • Zolpidem tartrate may cause serious side effects, including:
  • Call your healthcare provider right away if you find out that you have done any of the above activities after taking n- zolpidem tartrate.n n- Arrayn- zolpidem tartrateu00a0n- if you:
  • What is n- zolpidem tartrate?n
  • Who should not take n- zolpidem tartrate?
  • Symptoms of a serious allergic reaction to zolpidem can include:
  • What should I tell my healthcare provider before taking n- zolpidem tartrate?n n- Arrayn- may not be right for you. Before starting n- zolpidem tartrate, tell your healthcare provider about all of your health conditions, including if you:
  • Tell your healthcare provider about all of the medicines you taken- Do not take n- zolpidem tartrate n- with other medicines that can make you sleepy unless your healthcare provider tells you to.n n- Arrayn- zolpidem tartrate?
  • What are the possible side effects of n- zolpidem tartrate?n n- Arrayn- may cause serious side effects, including:
  • Call your healthcare provider right away if you have any of the above side effects or any other side effects that worry you while using n- zolpidem tartrate. n n- Arrayn- zolpidemu00a0tartrate n- are:
  • After you stop taking a sleep medicine,
  • These are not all the side effects of zolpidem tartrate. Ask your healthcare provider or pharmacist for more information.n Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. n n n
  • Keep zolpidemu00a0n- tartrate and all medicines out of reach of children.n n- Arrayn- zolpidem tartrate n n- Arrayn- tartrate tablets?n n- Arrayn- Arrayn- Arrayn- Arrayn- Aurobindo Pharma USA, Inc.n n- Aurobindo Pharma Limited
  • No data
  • No data

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