“We use cookies on this website to enhance your user experience and to personalise content. By clicking any link or continuing to use our Website you agree to our cookies as per our Privacy Policy. Read More” Ok, I agree

Zolpidem Tartrate (Zolpidem Tartrate)

Trade Name : Zolpidem Tartrate

Actavis Pharma, Inc.

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]

Delivery Process

Submit a Request

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.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

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.

Submit a Request

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.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

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 Actavis Pharma, Inc.. 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

Packaging and Delivery

Validated Cold Chain Shipment

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.

Inquire directly from our website and get 5% off on any medicine!

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.

Read more

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.

Read more
  • No data
  • No data
  • Zolpidem tartrate extended-release tabletsu00a0are 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 n
  • 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 dailyu00a0()
  • 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 7 to 8 hours remaining before the planned time of awakeningu00a0()
  • 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, USP are available as extended-release tablets containing 6.25 mg or 12.5 mg of zolpidem tartrate, USP for oral administration. Tablets are not scored.
  • Zolpidem Tartrate Extended-Release Tablets USP, 6.25 mg are white, round, biconvex, coated tablets debossed with A2 on one side and plain on the other side.
  • Zolpidem Tartrate Extended-Release Tablets USP, 12.5 mg are yellow, round, biconvex, coated tablets debossed with A1 on one side and plain on the other side.
  • Extended-Release Tablets: 6.25 mg and 12.5 mg. Tablets scored. ()
  • Zolpidem tartrate extended-release tablets are contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema n
  • Known hypersensitivity to zolpidem. ()
  • No data
  • CNS-depressant effects: Impaired alertness and motor coordination, including risk of morning impairment. Caution patients against driving and other activities requiring complete mental alertness the morning after use. ()
  • Need to evaluate for comorbid diagnoses: Re-valuate 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. ()
  • 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. ()
  • 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 Actavis at 1-800-432-8534 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.n
  • 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. Johnu2019s wort): Combination use may decrease effect ()
  • Ketoconazole: Combination use may increase effect ()
  • No data
  • No data
  • No data
  • Zolpidem Tartrate Extended-Release Tablets USP contain zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate extended-release tablets, USPu00a0are 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, 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.
  • Zolpidem Tartrate Extended-Release Tablets USPu00a0consist of a two-portion tablet: one portion that releases its drug content immediately and another portion that allows a delayed release of additional drug content.
  • Zolpidem Tartrate Extended-Release Tablets USPu00a0contain the following inactive ingredients: anhydrous lactose, colloidal anhydrous silica, colloidal silicon dioxide, hypromellose, light anhydrous silicic acid, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, povidone, silica, silicified microcrystalline cellulose, sodium bicarbonate, sodium lauryl sulfate, talc, tartaric acid, triethyl citrate, and titanium dioxide. Additionally, the 6.25 mg strength contains polyvinyl alcohol. The 12.5 mg strength also contains polydextrose, triacetin, and yellow iron oxide.
  • This product meets USP Dissolution Test 7.
  • 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, 9, and 40 times the MRHD of 12.5 mg/day (10 mg zolpidem base) based on mg/m body surface area and in rats, these doses are approximately 4, 18, and 80 times the MRHD based on mg/m body 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 4, 20, and 100 times the MRHD of 12.5 mg/day (10 mg zolpidem base) based on mg/mbody 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 100 times the MRHD based on mg/mbody surface area. The NOAEL for these effects is 20 times the MRHD based on an mg/m body surface area. There was no impairment of fertility at any dose tested.
  • u00a0
  • No data
  • Zolpidem Tartrate Extended-Release Tablets USP, 6.25 mg are composed of two portions* and are white, round, biconvex, unscored, coated tablets debossed with A2 on one side and plain on the other side and supplied as:
  • NDC Number Size
  • 0228-3481-11 bottle of 100
  • Each tablet contains 6.25 mg of zolpidem tartrate, USP.
  • Zolpidem Tartrate Extended-Release Tablets USP, 12.5 mg are composed of two portions* and are yellow, round, biconvex, unscored, coated tablets debossed with A1 on one side and plain on the other side and supplied as:
  • NDC Number Size
  • 0228-3482-11 bottle of 100
  • Each tablet contains 12.5 mg of zolpidem tartrate, USP.
  • *Portions are covered by the coating and are indistinguishable.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant, child-resistant container as defined in the USP.
  • 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.
  • CNS-Depressant Effects and Next-Day Impairment
  • Tell patients that zolpidem tartrate extended-release tablets can cause next-day impairment even when used as prescribed, and that this risk is increased if dosing instructions are not carefully followed. Caution patients against driving and other activities requiring complete mental alertness the day after use. Inform patients that impairment can be present despite feeling fully awake. Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients.
  • Severe Anaphylactic and Anaphylactoid Reactions
  • 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.
  • Sleep-Driving and other Complex Behaviors
  • Instruct patients and their families that sedative hypnotics can cause abnormal thinking and behavior change, including u201csleep drivingu201d and other complex behaviors while not being fully awake (preparing and eating food, making phone calls, or having sex). Tell patients to call you immediately if they develop any of these symptoms.
  • Suicide
  • Tell patients to immediately report any suicidal thoughts.
  • Alcohol and other Drugs
  • 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 extended-release tablets if they drank alcohol that evening or before bed.
  • Tolerance, Abuse, and Dependence
  • Tell patients not to increase the dose of zolpidem tartrate extended-release tablets on their own, and to inform you if they believe the drug u201cdoes not worku201d.
  • Administration Instructions
  • Patients should be counseled to take zolpidem tartrate extended-release tablets 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 extended-release tablets should notu00a0be taken with or immediately after a meal. Advise patients NOT to take zolpidem tartrate extended-release tablets 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 extended-release tablets. Advise patients that use of zolpidem tartrate extended-release tablets late in the third trimester may cause respiratory depression and sedation in neonates. Advise mothers who used zolpidem tartrate extended-release tablets during the late third trimester of pregnancy to monitor neonates for signs of sleepiness (more than usual), breathing difficulties, or limpness n
  • Lactation
  • Advise breastfeeding mothers using zolpidem tartrate extended-release tablets to monitor infants for increased sleepiness (more than usual), 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 extended-release tablets administration to minimize drug exposure to a breastfed infant .
  • Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USA
  • Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA
  • Rev. A 3/2019
  • ZOLPIDEMu00a0 TARTRATE (zol' pi dem tar' trate) 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?
  • 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?
  • Symptoms of a serious allergic reaction to zolpidem can include:
  • 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 doctoru00a0for medical advice about side effects. You may report side effects to FDA at 1u2013800u2013FDAu20131088.
  • How should I store zolpidem tartrate extended-release tablets?
  • Store zolpidem tartrate extended-release tablets at 68u00b0 to 77u00b0F (20u00b0 to 25u00b0C) [See USP Controlled Room Temperature].
  • 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 about zolpidem tartrate extended-release tablets call Actavis at 1-800-432-8534.
  • What are the ingredients in zolpidem tartrate extended-release tablets?
  • Active Ingredient:
  • Inactive Ingredients:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured by:Actavis Elizabeth LLCElizabeth, NJ 07207 USA
  • Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USA
  • NDC 0228--11
  • CIV
  • Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg
  • PHARMACIST: Dispense the Medication Guide provided separately to each patient.
  • 100 TabletsRx Only
  • Actavis
  • NDC 0228--11
  • CIV
  • Zolpidem Tartrate Extended-Release Tablets, USP 12.5 mg
  • PHARMACIST: Dispense the Medication Guide provided separately to each patient.
  • 100 TabletsRx Only
  • Actavis
  • u00a0
  • Arrayn- Array

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Desogestrel And Ethinyl Estradiol (Emoquette)

Manufacturer: REMEDYREPACK INC.

Presentation: KIT

Strength:

Pack Size:

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET

Strength: 2.5; .025 mg/1; mg/1

Pack Size:

Fluoxetine Hydrochloride (Fluoxetine)

Fluoxetine Hydrochloride (Fluoxetine)

Manufacturer: REMEDYREPACK INC.

Presentation: CAPSULE

Strength: 40 mg/1

Pack Size:

Metoprolol Succinate (Metoprolol Succinate)

Metoprolol Succinate (Metoprolol Succinate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, EXTENDED RELEASE

Strength: 25 mg/1

Pack Size:

Losartan Potassium (Losartan Potassium)

Losartan Potassium (Losartan Potassium)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, FILM COATED

Strength: 25 mg/1

Pack Size:

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Get Price

Are you an existing customer or a vendor of GNH India? Log in here to

View your Transaction
COMPANY
SERVICES
QUICK LINKS
CONTACT US
Registered Office Address:

Unit # G- 14, 15, 16, 17, Ground Floor, Prabhadevi Industrial Estate, Enterprises Industrial Premises, 408, Veer Sawarkar Road, Prabhadevi,
Mumbai 400025 India

US Office Address:

GNH Pharmaceuticals USA LLC,
Suite E # 499, 1235 EAST BLVD,
Charlotte, NC, 28203, U.S.A
TEL: +1 704 557 0412

Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.