Product image of Eszopiclone 3 mg/1 (Eszopiclone) 3 mg/1 TABLET, FILM COATED supplied by GNH India

Eszopiclone 3 mg/1

Active Ingredient:
Eszopiclone
Form:
TABLET, FILM COATED
Brand:
Eszopiclone
Origin:
USA

Eszopiclone 3 mg/1 (Eszopiclone TABLET, FILM COATED) 3 mg/1

Eszopiclone, the active ingredient in Eszopiclone 3 mg, is a non-benzodiazepine hypnotic (cyclopyrrolone) presented as a 3 mg/1 film-coated tablet for oral use. It is indicated for the treatment of insomnia in adults. GNH India supplies Eszopiclone 3 mg as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals and clinics worldwide.

Eszopiclone 3 mg is a Schedule IV controlled substance, classified under the therapeutic class of sedative-hypnotics for insomnia. It is available in the USA and is subject to regulatory guidelines ensuring its safety and efficacy.

Strength

3 mg/1

Pack Size

100 TABLET, FILM COATED in 1 BOTTLE (0093-5539-01)

Manufacturer / TM Owner

Teva Pharmaceuticals USA, Inc.

1
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Indications & Clinical Uses

Eszopiclone 3 mg is primarily used for the treatment of insomnia. It acts on the GABA receptor complex, enhancing the effects of the neurotransmitter GABA to promote sleep. The following are the key indications for Eszopiclone 3 mg:

  • Insomnia: Improves sleep onset and maintenance in adults with chronic or transient insomnia.

How It Works

  • Eszopiclone works as a positive allosteric modulator of the GABA_A receptor at the benzodiazepine binding site. By enhancing chloride ion influx, it produces sedative-hypnotic effects, which help in reducing sleep latency and improving sleep maintenance. This mechanism is distinct from benzodiazepines, making it a non-benzodiazepine hypnotic.

Side Effects

Eszopiclone 3 mg may cause various side effects, ranging from common to serious. It is important to be aware of these potential effects when using the medication.

Common Side Effects

  • Dizziness: May occur during the day after taking the medication.
  • Headache: A frequent side effect reported by users.
  • Nausea: Some patients may experience mild to moderate nausea.
  • Dry mouth: A common side effect that can be managed with hydration.
  • Unpleasant taste: Some users report a bitter or metallic taste after taking the medication.
  • Daytime drowsiness: May occur, especially if the medication is not taken immediately before bedtime.
  • Diarrhea: A less common but possible side effect.
  • Fatigue: Some patients may feel tired during the day.

Serious or Rare Side Effects

  • Complex sleep behaviors: Includes activities such as sleep-driving, which can be dangerous.
  • Memory impairment: May occur, especially if the medication is taken with less than a full night of sleep remaining.
  • Hallucinations: Rare but possible, especially in elderly patients.
  • Depression: Some patients may experience worsening of depressive symptoms.

Precautions & Warnings

Eszopiclone 3 mg should be used with caution and under the supervision of a healthcare provider. The following precautions should be considered:

  • Dosage adjustment: The total dose should not exceed 2 mg in elderly or debilitated patients.
  • Next-day impairment: Patients should be cautioned against driving or engaging in hazardous activities the day after use.
  • Alcohol and CNS depressants: Avoid concomitant use with alcohol or other CNS depressants to prevent additive effects.
  • Hepatic impairment: The total dose should not exceed 2 mg in patients with severe hepatic impairment.
  • CYP3A4 inhibitors: Caution should be exercised when coadministered with potent CYP3A4 inhibitors.
  • Store at room temperature: Keep in the original pack, protect from moisture.

Avoid Interactions

Eszopiclone 3 mg may interact with other medications, potentially altering its effectiveness or increasing the risk of side effects. The following interactions should be considered:

Major Interactions (Avoid)

  • Alcohol: Concomitant use increases the risk of CNS depression and complex sleep behaviors.
  • Other CNS depressants: Includes benzodiazepines, opioids, and tricyclic antidepressants, which can enhance the sedative effects of eszopiclone.
  • Ketoconazole: A potent CYP3A4 inhibitor that can significantly increase eszopiclone exposure.

Moderate Interactions (Monitor Closely)

  • Olanzapine: May result in a pharmacodynamic interaction affecting psychomotor function.
  • Lorazepam: May decrease each other’s Cmax by 22%, requiring close monitoring.
  • Paroxetine: No pharmacokinetic interaction has been detected, but monitoring is still recommended.

Frequently Asked Questions

Eszopiclone 3 mg is used for the treatment of insomnia in adults. It helps to reduce sleep latency and improve sleep maintenance by acting on the GABA receptor complex, enhancing the effects of the neurotransmitter GABA to promote sleep.

Eszopiclone works as a positive allosteric modulator of the GABA_A receptor at the benzodiazepine binding site. By enhancing chloride ion influx, it produces sedative-hypnotic effects, which help in reducing sleep latency and improving sleep maintenance. This mechanism is distinct from benzodiazepines, making it a non-benzodiazepine hypnotic.

The usual dose of Eszopiclone 3 mg is determined by a healthcare provider based on the patient's condition and response to the medication. The recommended starting dose is 1 mg, which can be increased to 2 mg or 3 mg if clinically indicated. The total dose should not exceed 3 mg once daily immediately before bedtime.

Eszopiclone is classified as a Category C drug for pregnancy, meaning that animal reproduction studies have shown an adverse effect on the fetus, and there are no adequate and well-controlled studies in humans. It should be used during pregnancy only if the potential benefits justify the potential risks. It is not known whether eszopiclone is excreted in human milk, so caution should be exercised when using it during breastfeeding.

To order Eszopiclone 3 mg from GNH India, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams across international markets. The team will ask you to confirm your trade or institutional credentials and will reply with pricing, availability, shipping, and the import paperwork.

Eszopiclone is a non-benzodiazepine hypnotic, which means it has a different mechanism of action compared to traditional benzodiazepines. It is less likely to cause dependence and has a lower risk of next-day impairment. However, it may still cause side effects such as dizziness, headache, and daytime drowsiness. The choice of sleep medication depends on individual patient factors and should be determined by a healthcare provider.

Eszopiclone 3 mg should be stored at room temperature, between 59°F to 86°F (15°C to 30°C). Keep the medication in the original pack and protect it from moisture. Ensure that it is stored out of reach of children and pets.

Eszopiclone 3 mg is administered orally, typically taken immediately before bedtime. It should be taken as directed by a healthcare provider. The medication should not be taken with or immediately after a high-fat meal, as this may reduce its effectiveness. It is important to follow the prescribed dosage and not to exceed the recommended dose.

The most serious risks associated with Eszopiclone 3 mg include complex sleep behaviors such as sleep-driving, memory impairment, and hallucinations. These risks are increased if the medication is taken with less than a full night of sleep remaining, if higher than the recommended dose is taken, or if it is co-administered with other CNS depressants. Patients should be monitored for these risks and should avoid activities that require full alertness the day after use.

Eszopiclone 3 mg should not be used by individuals who are allergic to eszopiclone or any of its inactive ingredients. It should be used with caution in elderly or debilitated patients, as well as in patients with severe hepatic impairment. It should also be avoided in patients with a history of complex sleep behaviors or those who have not had a full night of sleep. Pregnant or breastfeeding women should consult a healthcare provider before using eszopiclone.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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