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Eszopiclone (Lunesta)

Trade Name : Lunesta

Sunovion Pharmaceuticals Inc.

TABLET, COATED

Strength 1 mg/1

ESZOPICLONE

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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 Eszopiclone (Lunesta) which is also known as Lunesta and Manufactured by Sunovion Pharmaceuticals Inc.. It is available in strength of 1 mg/1 per ml. Read more

Eszopiclone (Lunesta) 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
  • No data
  • 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 LUNESTA. Some of these events may result in serious injuries, including death. Discontinue LUNESTA immediately if a patient experiences a complex sleep behavior (, ).
  • LUNESTA (eszopiclone) is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, LUNESTA administered at bedtime decreased sleep latency and improved sleep maintenance.n
  • The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).n
  • LUNESTA is indicated for the treatment of insomnia. LUNESTA has been shown to decrease sleep latency and improve sleep maintenance ()n
  • Use the lowest effective dose for the patient.n
  • Use the lowest dose effective for the patient ()n
  • Recommended initial dose is 1 mg, immediately before bedtime, with at least 7-8 hours remaining before the planned time of awakening. May increase dose if clinically indicated, to a maximum of 3 mg ()n
  • Geriatric or debilitated patients: Dose should not exceed 2 mg ()n
  • Patients with severe hepatic impairment, or taking potent CYP3A4 inhibitors: Dose should not exceed 2 mg ()n
  • Do not take with or immediately after a meal ()n
  • LUNESTA is available in 1 mg, 2 mg and 3 mg strengths for oral administration.n
  • LUNESTA 3 mg tablets are round, dark blue, film-coated, and identified with debossed markings of S193 on one side.n
  • LUNESTA 2 mg tablets are round, white, film-coated, and identified with debossed markings of S191 on one side.n
  • LUNESTA 1 mg tablets are round, light blue, film-coated, and identified with debossed markings of S190 on one side.n
  • Tablets: 1 mg, 2 mg, and 3 mg ()n
  • Arrayn- [see Warnings and Precautions ()].
  • LUNESTA is contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema .n
  • Patients who have experienced complex sleep behaviors after taking LUNESTA ()n
  • Known hypersensitivity to eszopiclone ()n
  • No data
  • CNS Depressant Effects:
  • Evaluate for Comorbid Diagnoses:
  • Severe Anaphylactic/Anaphylactoid Reactions
  • Abnormal Thinking and Behavioral Changes:
  • Worsening of Depression or Suicidal Thinking
  • Withdrawal Effects:
  • Elderly Patients:
  • Patients with Hepatic Impairment, Impaired Respiratory Function, Impaired Drug Metabolism or Hemodynamic Responses:
  • The following are described in more detail in the section of the label:n
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.n
  • The premarketing development program for LUNESTA included eszopiclone exposures in patients and/or normal subjects from two different groups of studies: approximately 400 normal subjects in clinical pharmacology/pharmacokinetic studies, and approximately 1550 patients in placebo-controlled clinical effectiveness studies, corresponding to approximately 263 patient-exposure years. The conditions and duration of treatment with LUNESTA varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, and short-term and longer-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.n
  • The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while the patient was receiving therapy following baseline evaluation.n
  • Most commonly observed adverse reactions (incidence u22652%) were unpleasant taste, headache, somnolence, respiratory infection, dizziness, dry mouth, rash, anxiety, hallucinations, and viral infections ()n
  • No data
  • CNS Depressants:
  • Rifampicin:
  • Ketoconazole:
  • No data
  • Pediatric Use:
  • 8.4
  • No data
  • In clinical trials with eszopiclone, one case of overdose with up to 36 mg of eszopiclone was reported in which the subject fully recovered. Since commercial marketing began, spontaneous cases of eszopiclone overdoses up to 270 mg (90 times the maximum recommended dose of eszopiclone) have been reported, in which patients have recovered. Fatalities related to LUNESTA overdoses were reported only in combination with other CNS drugs or alcohol.n
  • LUNESTA (eszopiclone) is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class. The chemical name of eszopiclone is (+)-(5S)-6-(5-chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b] pyrazin-5-yl 4-methylpiperazine-1-carboxylate. Its molecular weight is 388.81, and its empirical formula is CHClNO. Eszopiclone has a single chiral center with an ()-configuration. It has the following chemical structure:n
  • Eszopiclone is a white to light-yellow crystalline solid. Eszopiclone is very slightly soluble in water, slightly soluble in ethanol, and soluble in phosphate buffer (pH 3.2).n
  • Eszopiclone is formulated as film-coated tablets for oral administration. LUNESTA tablets contain 1 mg, 2 mg, or 3 mg eszopiclone and the following inactive ingredients: calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and triacetin. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2.n
  • No data
  • No data
  • The effect of LUNESTA on reducing sleep latency and improving sleep maintenance was established in studies with 2100 subjects (ages 18-86) with chronic and transient insomnia in six placebo-controlled trials of up to 6 months' duration. Two of these trials were in elderly patients (n=523). Overall, at the recommended adult dose (2-3 mg) and elderly dose (1-2 mg), LUNESTA significantly decreased sleep latency and improved measures of sleep maintenance (objectively measured as WASO and subjectively measured as total sleep time).n
  • LUNESTA 3 mg tablets are round, dark blue, film-coated, and identified with debossed markings of S193 on one side, and are supplied as:n
  • NDC 63402-193-10 bottle of 100 tabletsNDC 63402-193-03 bottle of 30 tabletsn
  • LUNESTA 2 mg tablets are round, white, film-coated, and identified with debossed markings of S191 on one side, and are supplied as:n
  • NDC 63402-191-10 bottle of 100 tabletsn
  • NDC 63402-191-03 bottle of 30 tabletsn
  • LUNESTA 1 mg tablets are round, light blue, film-coated, and identified with debossed markings of S190 on one side, and are supplied as:n
  • NDC 63402-190-30 bottle of 30 tabletsn
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [see USP Controlled Room Temperature].n
  • See FDA-approved patient labeling ().n
  • Inform patients and their families about the benefits and risks of treatment with LUNESTA. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with LUNESTA and with each prescription refill. Review the LUNESTA Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that LUNESTA should be taken only as prescribed.n
  • MEDICATION GUIDE
  • LUNESTA (lu016b'-nes''-tu0103) Tablets, Coated C-IV
  • (eszopiclone)
  • Read the Medication Guide that comes with LUNESTA 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 doctor about your medical condition or treatment.n
  • What is the most important information I should know about LUNESTA?
  • LUNESTA may cause serious side effects, including:
  • Complex sleep behaviors that have caused serious injury and death.
  • Reported activities and behaviors include:
  • Stop taking LUNESTA and call your healthcare provider right away if you find out that you have done any of the above activities after taking LUNESTA.
  • The morning after you take LUNESTA your ability to drive safely and think clearly may be decreased. You also may experience sleepiness during the day.
  • Do not take LUNESTA if you:
  • _________________________________________________________________________n
  • WHAT ISnn- LUNESTA?
  • LUNESTA is a sedative-hypnotic (sleep) medicine. LUNESTA is used in adults for the treatment of a sleep problem called insomnia. Symptoms of insomnia include:n
  • LUNESTA is not for children.n
  • Who should not take LUNESTA?
  • LUNESTA may not be right for you. Before starting LUNESTA, tell your doctor about all of your health conditions, including if you:
  • Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. 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 doctor and pharmacist each time you get a new medicine.n
  • How should I take LUNESTA?
  • What are the possible side effects of LUNESTA?
  • Possible serious side effects of LUNESTA include:
  • Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using LUNESTA.
  • The most common side effects of LUNESTA are:
  • These are not all the side effects of LUNESTA. Ask your doctor 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.n
  • How should I store LUNESTA?
  • General Information about LUNESTA
  • This Medication Guide summarizes the most important information about LUNESTA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about LUNESTA that is written for healthcare professionals.n
  • What are the ingredients in LUNESTA?
  • Active Ingredient:
  • Inactive Ingredients:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.n
  • Manufactured for:n Marlborough, MA 01752 USAn
  • u00a9 2019 Sunovion Pharmaceuticals Inc. All rights reserved.LUNESTA is a registered trademark of Sunovion Pharmaceuticals Inc.Revised: 08/201910161-03n
  • 1 MG BOTTLE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 1mg
  • NDC 63402-190-30n
  • 30 Tabletsn
  • Lunestan
  • (eszopiclone) Tabletsn
  • 1 mg C-IVn
  • DISPENSER: Each time Lunesta isn
  • dispensed give the patient a medicationn
  • guide, also provided at www.Lunesta.comn
  • or 1-888-394-7377.n
  • SUNOVIONn
  • Rx Onlyn
  • ______________________________________________________________________________n
  • 2 MG BOTTLE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 2mg
  • NDC 63402-191-03n
  • 30 Tabletsn
  • Lunestan
  • (eszopiclone) Tabletsn
  • 2 mg C-IVn
  • DISPENSER: Each time Lunesta isn
  • dispensed give the patient a medicationn
  • guide, also provided at www.Lunesta.comn
  • or 1-888-394-7377.n
  • SUNOVIONn
  • Rx Onlyn
  • 3 MG BOTTLE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 3mg
  • NDC 63402-193-03n
  • 30 Tabletsn
  • Lunestan
  • (eszopiclone) Tabletsn
  • 3 mg C-IVn
  • DISPENSER: Each time Lunesta isn
  • dispensed give the patient a medicationn
  • guide, also provided at www.Lunesta.comn
  • or 1-888-394-7377.n
  • SUNOVIONn
  • Rx Onlyn

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