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Zolpidem Tartrate (Ambien)

Trade Name : Ambien

Sanofi-Aventis U.S. 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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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

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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 (Ambien) which is also known as Ambien and Manufactured by Sanofi-Aventis U.S. LLC. It is available in strength of 5 mg/1 per ml. Read more

Zolpidem Tartrate (Ambien) 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
  • Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of AMBIEN. Some of these events may result in serious injuries, including death. Discontinue AMBIEN 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 AMBIEN. Some of these events may result in serious injuries, including death. Discontinue AMBIEN immediately if a patient experiences a complex sleep behavior. (, )
  • No data
  • AMBIEN (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. AMBIEN has been shown to decrease sleep latency for up to 35 days in controlled clinical studies .
  • The clinical trials performed in support of efficacy were 4u20135 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
  • AMBIEN, a 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 of 10 mg daily ()
  • 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 7u20138 hours remaining before the planned time of awakening ()
  • Geriatric patients and patients with mild to moderate hepatic impairment: Recommended dose is 5 mg for men and women ()
  • Lower doses of CNS depressants may be necessary when taken concomitantly with AMBIEN ()
  • The effect of AMBIEN may be slowed if taken with or immediately after a meal ()
  • AMBIEN is available in 5 mg and 10 mg strength tablets for oral administration. Tablets are not scored.
  • AMBIEN 5 mg tablets are capsule-shaped, pink, film coated, with AMB 5 debossed on one side and 5401 on the other.
  • AMBIEN 10 mg tablets are capsule-shaped, white, film coated, with AMB 10 debossed on one side and 5421 on the other.
  • 5 mg and 10 mg tablets. Tablets scored. ()
  • AMBIEN is contraindicated in patients
  • Patients who have experienced complex sleep behaviors after taking AMBIEN ()
  • 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 AMBIEN 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:
  • u00a0u00a0Short-term (<10 nights): Drowsiness, dizziness, and diarrhea
  • u00a0u00a0Long-term (28u201335 nights): Dizziness and drugged feelings ()
  • 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 AMBIEN 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
  • AMBIEN contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. AMBIEN 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:
  • 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.
  • Each AMBIEN tablet includes the following inactive ingredients: hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. The 5 mg tablet also contains FD&C Red No. 40, iron oxide colorant, and polysorbate 80.
  • No data
  • No data
  • No data
  • AMBIEN 5 mg tablets are capsule-shaped, pink, film coated, with AMB 5 debossed on one side and 5401 on the other and supplied as:
  • AMBIEN 10 mg tablets are capsule-shaped, white, film coated, with AMB 10 debossed on one side and 5421 on the other and supplied as:
  • Store at controlled room temperature 20u00b0Cu201325u00b0C (68u00b0Fu201377u00b0F).
  • 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 AMBIEN. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with AMBIEN and with each prescription refill. Review the AMBIEN Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that AMBIEN should be taken only as prescribed.
  • MEDICATION GUIDEn- AMBIEN(n- )n- tablets C-IV
  • Read the Medication Guide that comes with AMBIEN 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 AMBIEN?
  • AMBIEN may cause serious side effects, including:
  • Stop taking AMBIEN and call your healthcare provider right away if you find out that you have done any of the above activities after taking AMBIEN.
  • Do not take AMBIEN if you:
  • What is AMBIEN?
  • AMBIEN is a sedative-hypnotic (sleep) medicine. AMBIEN is used in adults for the short-term treatment of a sleep problem called insomnia (trouble falling asleep).
  • AMBIEN is not recommended for use in children under the age of 18 years.
  • Who should not take AMBIEN?
  • What should I tell my healthcare provider before taking AMBIEN?
  • AMBIEN may not be right for you. Before starting AMBIEN, 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 AMBIEN?
  • What are the possible side effects of AMBIEN?
  • AMBIEN 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 AMBIEN.
  • The most common side effects of AMBIEN are:
  • After you stop taking a sleep medicine,
  • These are not all the side effects of AMBIEN. 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 1u2013800u2013FDAu20131088.
  • How should I store AMBIEN?
  • Keep AMBIEN and all medicines out of reach of children.
  • General Information about the safe and effective use of AMBIEN
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AMBIEN for a condition for which it was not prescribed. Do not share AMBIEN 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 AMBIEN. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about AMBIEN that is written for healthcare professionals.
  • For more information, call 1-800-633-1610.
  • What are the ingredients in AMBIEN?
  • Active Ingredient:
  • Inactive Ingredients:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • sanofi-aventis U.S. LLCBridgewater, NJ 08807A SANOFI COMPANY
  • Revised: August 2019
  • u00a92019 sanofi-aventis U.S. LLC
  • A-031 NDC
  • AMBIENn n
  • 5 mg
  • Dispense with Medication Guide
  • Rx only
  • 100
  • SANOFI
  • A-231NDC
  • AMBIENn n
  • 10 mg
  • Dispense with Medication Guide
  • Rx only
  • 100
  • SANOFI

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