Sleepwel Tablet

Sleepwel 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.

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.

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.

Alcohol (which causes sedation) and drugs that have sedating effects should not be used with Sleepwel since their sedating effects, when added to those of Sleepwel, may cause excessive sedation.

Depression, Severe Chronic Obstructive Lung Disease, Severe Liver Disease, Weakened Patient, Having thoughts of Suicide.

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.

Sleepwel 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 Sleepwel 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 Sleepwel over a period of 6 months in clinical trials.

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

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

Miscellaneous sedatives & hypnotics

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.