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Zolpidem Tartrate (Edluar)

Trade Name : Edluar

Meda Pharmaceuticals

TABLET

Strength 10 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 (Edluar) which is also known as Edluar and Manufactured by Meda Pharmaceuticals. It is available in strength of 10 mg/1 per ml. Read more

Zolpidem Tartrate (Edluar) 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 Warningu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0XX/2019Contraindications () u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 XX/2019Warnings and Precautions, Complex Sleep Behaviors () u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 XX/2019Warnings and Precautions, CNS Depressant Effects and Next-Day Impairment () u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 12/2018n
  • Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of Edluar. Some of these events may result in serious injuries, including death. Discontinue Edluar 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 Edluar. Some of these events may result in serious injuries, including death. Discontinue Edluar immediately if a patient experiences a complex sleep behavior. (, )
  • Edluar (zolpidem tartrate) sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation .
  • The clinical trials performed with zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
  • Edluar, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate has been shown to decrease sleep latency for up to 35 days in controlled clinical studies. ()
  • No data
  • Edluar is available in 5 mg and 10 mg strength tablets for sublingual administration. Tablets are scored.
  • Edluar 5 mg sublingual tablets are round white, flat-faced, bevel-edged, with debossed V on one side.
  • Edluar 10 mg sublingual tablets are round white, flat-faced, bevel-edged, with debossed X on one side.
  • Sublingual tablets: 5 mg and 10 mg. Tablets scored. ()
  • Edluar is contraindicated in patients:
  • 4n- 5.1
  • No data
  • 5.8n- 9.3
  • The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
  • Most commonly observed adverse reactions were:
  • To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-866-444-7799 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • 5.1n- 7.1
  • No data
  • 5.4n- 8.4
  • No data
  • No data
  • Edluar contains zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Edluar is available in 5 mg and 10 mg strength tablets for sublingual administration.
  • Chemically, zolpidem tartrate 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 Edluar tablet includes the following inactive ingredients: mannitol, colloidal silicon dioxide, silicified microcrystalline cellulose, croscarmellose sodium, saccharin sodium, and magnesium stearate.
  • No data
  • No data
  • No data
  • Edluar is supplied as sublingual tablets in two dosage strengths: Tablets are not scored.
  • Edluar 5 mg sublingual tablets are round white tablets, flat-faced, bevel-edged with debossed V on one side and supplied as:
  • NDC Numberu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Size
  • The blister packs consist of aluminum/aluminum Child Resistant Control (CRC) blisters.
  • Edluar 10 mg sublingual tablets are round white tablets, flat-faced, bevel-edged with debossed X on one side and supplied as:
  • NDC Numberu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Size
  • The blister packs consist of aluminum/aluminum Child Resistant Control (CRC) blisters.
  • Store at controlled room temperature 20-25u00b0C (68-77u00b0F). Protect from light and moisture.
  • See FDA-approved patient labeling ()
  • Inform patients and their families about the benefits and risks of treatment with Edluar. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with Edluar and with each prescription refill. Review the Edluar Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that Edluar should be taken only as prescribed.
  • Complex Sleep Behaviors
  • Instruct patients and their families that Edluar may cause complex sleep behaviors, including sleep-walking, sleep-driving, preparing and eating food, making phone calls, or having sex while not being fully awake. Serious injuries and death have occurred during complex sleep behavior episodes. Tell patients to discontinue Edluar and notify their healthcare provider immediately if they develop any of these symptoms .
  • CNS-depressant Effects and Next-Day Impairment
  • Tell patients that Edluar has the potential to cause next-day impairment, and that this risk is increased if dosing instructions are not carefully followed. Tell patients to wait for at least 8 hours after dosing before driving or engaging in other activities requiring full mental alertness. 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 .
  • 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 Edluar if they drank alcohol that evening or before bed.
  • Tolerance, Abuse, and Dependence
  • Tell patients not to increase the dose of Edluar on their own, and to inform you if they believe the drug u201cdoes not worku201d.
  • Pregnancy
  • Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Edluar. Advise patients that use of Edluar late in the third trimester may cause respiratory depression and sedation in neonates. Advise mothers who used Edluar 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 Edluar to monitor infants for increased sleepiness, breathing difficulties, or limpness. Instruct nursing 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 Edluar administration to minimize drug exposure to a breastfed infant n
  • Administration Instructions
  • Patients should be counseled to take Edluar right before they get into bed and only when they are able to stay in bed a full night (7-8 hours) before being active again. Edluar tablets should not be taken with or immediately after a meal. Advise patients NOT to take Edluar when drinking alcohol that evening or before bed. Edluar sublingual tablet should be placed under the tongue, where it will disintegrate. The tablet should not be swallowed and the tablet should not be taken with water.
  • Medication Guiden- Edluar [EDu2019 u2013 loo-ahr]
  • Read this Medication Guide that comes with Edluar 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 Edluar?
  • Edluar may cause serious side effects, including:
  • Stop taking Edluar and call your healthcare provider right away if you find out that you have done any of the above activities after taking Edluar.
  • Do not take Edluar if you:
  • What is Edluar?
  • Edluar is a sedative-hypnotic (sleep) medicine. Edluar is used in adults for the short-term treatment of a sleep problem called insomnia (trouble falling asleep).
  • It is not known if Edluar is safe and effective in children under the age of 18 years.
  • Edluar is a class four (C-IV) federally controlled substance because it can be abused or lead to dependence. Keep Edluar in a safe place to prevent misuse and abuse. Selling or giving away Edluar may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
  • Who should not take Edluar?
  • Symptoms of a serious allergic reaction to zolpidem can include:
  • What should I tell my healthcare provider before taking Edluar?
  • Edluar may not be right for you. Before starting Edluar, 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.
  • Do not take Edluar with other medicines that can make you sleepy, unless directed by your healthcare provider.
  • 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 Edluar?
  • What are the possible side effects of Edluar?
  • Edluar 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 Edluar.
  • The most common side effects of Edluar are:
  • You may still feel drowsy the next day after taking Edluar.
  • After you stop taking a sleep medicine
  • These are not all the side effects of Edluar. Ask your doctor or pharmacist for more information.
  • Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store Edluar?
  • Keep Edluar and all medicines out of reach of children.
  • General information about the safe and effective use of Edluar
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
  • Do not use Edluar for a condition for which it was not prescribed.
  • Do not share Edluar with other people, even if you think 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 Edluar.
  • If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Edluar that is written for healthcare professionals.
  • For more information about Edluar, go to or call Meda Pharmaceuticals Inc. at 1-866-444-7799.
  • What are the ingredients in Edluar?
  • Active Ingredient:
  • Inactive Ingredients:
  • This Medication Guide has been approved by U.S. Food and Drug Administration.
  • u00a0
  • Manufactured by:Recipharm Stockholm AB, Sweden for Meda Pharmaceuticals Inc.
  • u00a0
  • Distributed by:Meda Pharmaceuticals Inc.Somerset, NJ 08873-4120
  • u00a92019 Mylan Specialty LPU.S. Patents 6,761,910; 8,512,747; 9,265,720; 9,597,281
  • EDLUAR is a registered trademark of Meda Pharmaceuticals Inc., a Mylan company.
  • The brands listed are trademarks of their respective owners.
  • IG-6010-XX4u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Rev. XX/2019u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0797139
  • Rx Onlyu00a0u00a0u00a0NDC
  • EDLUAR 5 mgu00a0u00a0u00a0CIV
  • Federal Lawrequired dispensingof EDLUAR withthe MedicationGuide enclosed
  • Each sublingual tablet (to be placed under the tongue) contains 5 mgof zolpidem tartrate. See prescribing information for dosage information.
  • 30 Sublingual Tablets
  • Store at controlled room temperature 20-25u00baC (68-77u00baF). Protect from lightand moisture. Do not use if blisters are torn, or seal is broken.
  • UC-605030-03 Rev. 5/2017
  • Manufactured by:Recipharm Stockholm AB, Sweden forMeda Pharmaceuticals Inc.Made in Sweden
  • Distributed by:Meda Pharmaceuticals Inc.Somerset, New Jersey
  • 08873-4120
  • U.S. Patents 6,761,910; 8,512,747
  • MEDA and EDLUAR are registered trademarks ofMeda AB or a related entity.
  • Rx Onlyu00a0u00a0u00a0NDC
  • EDLUAR 10 mgu00a0u00a0u00a0CIV
  • Federal Lawrequired dispensingof EDLUAR withthe MedicationGuide enclosed
  • Each sublingual tablet (to be placed under the tongue) contains 10 mgof zolpidem tartrate. See prescribing information for dosage information.
  • 30 Sublingual Tablets
  • Store at controlled room temperature 20-25u00baC (68-77u00baF). Protect from lightand moisture. Do not use if blisters are torn, or seal is broken.
  • UC-601030-03 Rev. 5/2017
  • Manufactured by:Recipharm Stockholm AB, Sweden forMeda Pharmaceuticals Inc.Made in Sweden
  • Distributed by:Meda Pharmaceuticals Inc.Somerset, New Jersey
  • 08873-4120
  • U.S. Patents 6,761,910; 8,512,747
  • MEDA and EDLUAR are registered trademarks ofMeda AB or a related entity.

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