Zopilone Tablet 2 mg

Zopilone Tablet

Generic Name: Eszopiclone

Strength: 2 mg

Dosage Form: Tablet

Manufacturer: Incepta Pharmaceuticals Ltd

Indications

Zopilone is indicated for the managment of insomnia, Including difficulty in falling asleep, difficulty in maintaining sleep during the night, and waking up too early in the morning.

Pharmacology

Eszopiclone (s-isomer of Zopiclone) is a sedative/hypnotic. It is a non-benzodiazepine that works via interaction with GABA-receptor complexes. It is rapidly absorbed and have elimination half-life (t _1/2) of approx. 6 hours in non-elderly adults. In the elderly, half life is approx. 9 hours.

Dosage Information

Adult dose: The dose of Eszopiclone should be individualized. The recommended oral starting dose for most non-elderly adults (ages 18 to 64) is 2 mg immediately before bedtime. Dosing can be initiated at or increased to 3 mg as clinically indicated. The recommended oral starting dose for elderly patients ( ages 65 and older) who have difficulty falling asleep is 1 mg immediately before bedtime. In these patients, the dose may be increased to 2 mg as clinically indicated. For elderly patients who have difficulty staying asleep, the recommended dose is 2 mg immediately before bedtime.

Pediatric dose: Pediatric dosing is not available.

Taking Eszopiclone with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of Eszopiclone on sleep latency.

Side Effects

The most common side effects of sleep medicines are Drowsiness, dizziness, lightheadedness, hallucination, difficulty with coordination.

Precautions

Zopilone should be administered with caution in patients exhibiting signs and symptoms of depression. Therefore, the smallest dose feasible should be prescribed to the patient. Caution should be exercised in administration of Zopilone to patients with compromised respiratory function. Use of benzodiazepines and similar agents may lead to physical and psychological dependence. Tolerance may develop after repeated use of benzodiazepines and benzodiazepine-like agents for a few weeks. However, no evidence of developed tolerance was seen with Zopilone over a period of 6 months in clinical trials.

Safety information: Zopilone should only be taken immediatetly before bedtime. Patients should not engage in any activity after taking Zopilone that requires complete alertness , such as driving car or operating machinery etc. Patient should not use alcohol while taking Zopilone .

Adult dose: The dose of Eszopiclone should be individualized. The recommended oral starting dose for most non-elderly adults (ages 18 to 64) is 2 mg immediately before bedtime. Dosing can be initiated at or increased to 3 mg as clinically indicated. The recommended oral starting dose for elderly patients ( ages 65 and older) who have difficulty falling asleep is 1 mg immediately before bedtime. In these patients, the dose may be increased to 2 mg as clinically indicated. For elderly patients who have difficulty staying asleep, the recommended dose is 2 mg immediately before bedtime.

Pediatric dose: Pediatric dosing is not available.

Taking Eszopiclone with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of Eszopiclone on sleep latency.

The most common side effects of sleep medicines are Drowsiness, dizziness, lightheadedness, hallucination, difficulty with coordination.

Eszopiclone is pregnancy category C. There are no adequate and well-controlled studies of Eszopiclone in pregnant women. Eszopiclone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Eszopiclone is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Eszopiclone is administered to a nursing woman.

Zopilone should be administered with caution in patients exhibiting signs and symptoms of depression. Therefore, the smallest dose feasible should be prescribed to the patient. Caution should be exercised in administration of Zopilone to patients with compromised respiratory function. Use of benzodiazepines and similar agents may lead to physical and psychological dependence. Tolerance may develop after repeated use of benzodiazepines and benzodiazepine-like agents for a few weeks. However, no evidence of developed tolerance was seen with Zopilone over a period of 6 months in clinical trials.

Safety information: Zopilone should only be taken immediatetly before bedtime. Patients should not engage in any activity after taking Zopilone that requires complete alertness , such as driving car or operating machinery etc. Patient should not use alcohol while taking Zopilone .

There is limited pre-marketing clinical experience with the effects of an over dosage of Zopilone. In clinical trials with Zopilone, one case of overdose with up to 36 mg of Zopilone was reported in which the subject is fully recovered.