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Zolpidem Tartrate (Zolpidem Tartrate)

Trade Name : Zolpidem Tartrate

Winthrop U.S.

TABLET, FILM COATED, EXTENDED RELEASE

Strength 6.25 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 Winthrop U.S.. It is available in strength of 6.25 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
  • Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of Zolpidem Tartrate Extended-Release Tablets. Some of these events may result in serious injuries, including death. Discontinue Zolpidem Tartrate Extended-Release Tablets 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 Extended-Release Tablets. Some of these events may result in serious injuries, including death. Discontinue ZOLPIDEM TARTRATE Extended-Release Tablets immediately if a patient experiences a complex sleep behavior. (, )
  • No data
  • Zolpidem Tartrate Extended-Release Tablets are indicated for the 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.
  • Zolpidem Tartrate Extended-Release Tablets, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. ()
  • No data
  • Use the lowest dose effective for the patient and must not exceed a total of 12.5 mg daily ()
  • 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 7u20138 hours remaining before the planned time of awakening ()
  • Geriatric patients and patients with mild to moderate hepatic impairment: Recommended dose is 6.25 mg for men and women ()
  • Lower doses of CNS depressants may be necessary when taken concomitantly with Zolpidem Tartrate Extended-Release Tablets ()
  • Tablets to be swallowed whole, not to be crushed, divided or chewed ()
  • The effect of Zolpidem Tartrate Extended-Release Tablets may be slowed if taken with or immediately after a meal ()
  • Zolpidem Tartrate Extended-Release Tablets are available as extended-release tablets containing 6.25 mg or 12.5 mg of zolpidem tartrate for oral administration. Tablets are not scored.
  • Zolpidem Tartrate Extended-Release Tablets 6.25 mg tablets are pink, round, biconvex, and debossed with ZCR on one side.
  • Zolpidem Tartrate Extended-Release Tablets 12.5 mg tablets are blue, round, biconvex, and debossed with ZCR on one side.
  • Extended-Release Tablets: 6.25 mg and 12.5 mg. Tablets scored. ()
  • Zolpidem Tartrate Extended-Release Tablets is contraindicated in patients
  • Patients who have experienced complex sleep behaviors after taking Zolpidem Tartrate Extended-Release Tablets ()
  • Known hypersensitivity to zolpidem ()
  • No data
  • CNS-Depressant Effects: Impaired alertness and motor coordination, including risk of morning impairment. Risk increases with dose and use with other CNS depressants and alcohol. Caution patients against driving and other activities requiring complete mental alertness the morning after 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 Extended-Release Tablets 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 (>10% in either elderly or adult patients) are: headache, next-day somnolence, and dizziness ()
  • To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • CNS depressants, including alcohol: Possible adverse additive CNS-depressant effects (, )
  • Imipramine: Decreased alertness observed ()
  • Chlorpromazine: Impaired alertness and psychomotor performance observed ()
  • CYP3A4 inducers (rifampin or St. John's wort): Combination use may decrease effect ()
  • Ketoconazole: Combination use may increase effect ()
  • 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 Extended-Release Tablets 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. (, )
  • No data
  • No data
  • Zolpidem Tartrate Extended-Release Tablets contain zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem Tartrate Extended-Release Tablets are available in 6.25 mg and 12.5 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:
  • Zolpidem tartrate 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.
  • Zolpidem Tartrate Extended-Release Tablet consists of a coated two-layer tablet: one layer that releases its drug content immediately and another layer that allows a slower release of additional drug content. The 6.25 mg Zolpidem Tartrate Extended-Release tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, red ferric oxide, sodium starch glycolate, and titanium dioxide. The 12.5 mg Zolpidem Tartrate Extended-Release tablet contains the following inactive ingredients: colloidal silicon dioxide, FD&C Blue #2, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, sodium starch glycolate, titanium dioxide, and yellow ferric oxide.
  • No data
  • No data
  • No data
  • Zolpidem Tartrate Extended-Release 6.25 mg tablets are composed of two layers and are coated, pink, round, biconvex, debossed with ZCR on one side and supplied as:
  • Zolpidem Tartrate Extended-Release 12.5 mg tablets are composed of two layers and are coated, blue, round, biconvex, debossed with ZCR on one side and supplied as:
  • Store between 15u00b0Cu201325u00b0C (59u00b0Fu201377u00b0F). Limited excursions permissible up to 30u00b0C (86u00b0F).
  • 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 Extended-Release Tablets. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with Zolpidem Tartrate Extended-Release Tablets and with each prescription refill. Review the Zolpidem Tartrate Extended-Release Tablets Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that Zolpidem Tartrate Extended-Release Tablets should be taken only as prescribed.
  • MEDICATION GUIDEZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS C-IV
  • Read the Medication Guide that comes with ZOLPIDEM TARTRATE Extended-Release Tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.
  • What is the most important information I should know about ZOLPIDEM TARTRATE Extended-Release Tablets?
  • ZOLPIDEM TARTRATE Extended-Release Tablets may cause serious side effects including complex sleep behaviors that have caused serious injury and death.n- you mayn- not know
  • Stop taking ZOLPIDEM TARTRATE Extended-Release Tablets and call your healthcare provider right away if you find out that you have done any of the above activities after taking ZOLPIDEM TARTRATE Extended-Release Tablets.
  • You should not drive a car or do things that require clear thinking the day after you take ZOLPIDEM TARTRATE Extended-Release Tablets.
  • Do not take ZOLPIDEM TARTRATE Extended-Release Tablets if you:
  • What are ZOLPIDEM TARTRATE Extended-Release Tablets?
  • ZOLPIDEM TARTRATE Extended-Release Tablets are a sedative-hypnotic (sleep) medicine. ZOLPIDEM TARTRATE Extended-Release Tablets are used in adults for the treatment of a sleep problem called insomnia. Symptoms of insomnia include:
  • ZOLPIDEM TARTRATE Extended-Release Tablets are not recommended for use in children under the age of 18 years.
  • Who should not take ZOLPIDEM TARTRATE Extended-Release Tablets?
  • What should I tell my healthcare provider before taking ZOLPIDEM TARTRATE Extended-Release Tablets?
  • ZOLPIDEM TARTRATE Extended-Release Tablets may not be right for you. Before starting ZOLPIDEM TARTRATE Extended-Release Tablets, tell your healthcare provider about all of your health conditions, including if you:
  • Tell your healthcare provider about all of the medicines you take
  • Medicines can interact with each other, sometimes causing serious side effects.n
  • Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.
  • How should I take ZOLPIDEM TARTRATE Extended-Release Tablets?
  • What are the possible side effects of ZOLPIDEM TARTRATE Extended-Release Tablets?
  • ZOLPIDEM TARTRATE Extended-Release Tablets 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 ZOLPIDEM TARTRATE Extended-Release Tablets.
  • The most common side effects of ZOLPIDEM TARTRATE Extended-Release Tablets are:
  • After you stop taking a sleep medicine,
  • These are not all the side effects of ZOLPIDEM TARTRATE Extended-Release Tablets. Ask your healthcare provider or pharmacist for more information.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store ZOLPIDEM TARTRATE Extended-Release Tablets?
  • Store ZOLPIDEM TARTRATE Extended-Release Tablets at room temperature, 59u00b0F to 77u00b0F (15u00b0C to 25u00b0C).
  • Keep ZOLPIDEM TARTRATE Extended-Release Tablets and all medicines out of reach of children.
  • General Information about the safe and effective use of ZOLPIDEM TARTRATE Extended-Release Tablets
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZOLPIDEM TARTRATE Extended-Release Tablets for a condition for which it was not prescribed. Do not share ZOLPIDEM TARTRATE Extended-Release Tablets with other people, even if they have the same symptoms that you have. It may harm them and it is against the law.
  • This Medication Guide summarizes the most important information about ZOLPIDEM TARTRATE Extended-Release Tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ZOLPIDEM TARTRATE Extended-Release Tablets that is written for healthcare professionals.
  • For more information, call 1-800-633-1610.
  • What are the ingredients in ZOLPIDEM TARTRATE Extended-Release Tablets?
  • Active Ingredient:
  • Inactive Ingredients:
  • The 6.25 mg tablets contain: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, red ferric oxide, sodium starch glycolate, and titanium dioxide.
  • The 12.5 mg tablets contain: colloidal silicon dioxide, FD&C Blue #2, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, potassium bitartrate, sodium starch glycolate, titanium dioxide, and yellow ferric oxide.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Winthrop U.S.,
  • a business of sanofi-aventis U.S. LLCBridgewater, NJ 08807A SANOFI COMPANY
  • Revised: August 2019
  • u00a92019 sanofi-aventis U.S. LLC
  • NDC
  • Winthrop
  • Zolpidem Tartrate Extended-ReleaseCIV
  • 6.25 n
  • Dispense with Medication Guide
  • Rx only100 Tablets
  • SANOFI
  • NDC
  • Winthrop
  • Zolpidem Tartrate Extended-ReleaseCIV
  • 12.5 n
  • Dispense with Medication Guide
  • Rx only100 Tablets
  • SANOFI

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