SLEEPIL

Eszopiclone

Description:

Sleepil (Eszopiclone) is a nonbenzodiazepine hypnotic agent, which is the active stereoisomer of zopiclone. US FDA has recommended this drug for chronic insomnia. It also minimizes the side effects of benzodiazepines.

Composition:

Sleepil 1 tablet: Each tablet contains Eszopiclone INN 1 mg.

Sleepil 2 tablet: Each tablet contains Eszopiclone INN 2 mg.

Indications:

Sleepil is indicated for the treatment of insomnia.

Dosage & Administration:

For non-elderly adults: The recommended starting dose is 2 mg immediately before bedtime.

For elderly patients : The recommended starting dose for elderly patients whose primary complaint is difficulty falling asleep is 1 mg immediately before bedtime. The dose may be increased to 2 mg if clinically indicated. For elderly patients whose primary complaint is difficulty staying asleep, the recommended dose is 2 mg immediately before bedtime.

Contraindications:

It is contraindicated in patients with depression, liver disease, asthma, bronchitis & respiratory disease.

Side-effects:

The most common side effects are drowsiness, dizziness, lightheadedness, difficulty with coordination, memory loss or amnesia.

Precautions:

Do not take this drug in the morning or not take 2 doses at once. Sleepil should be used with caution in patients with diseases or conditions that could affect metabolism or hemodynamic responses. Sedative or hypnotic drugs should be administered with caution to patients exhibiting signs and symptoms of depression.

Use in Special Groups: 

Pregnancy : Eszopiclone is a Pregnancy Category C drug. Therefore, it should not be used during pregnancy.

Lactation : It is not known whether it is excreted in breast milk. Caution should be exercised when administered to a nursing mother.

Premenopausal & menopausal women: It is helpful for the treatment of insomnia in premenopausal & menopausal women.  

Paediatric Use: Safety and effectiveness in children have not been established.

Elderly patients: It is safe for elderly patients.

Drug Interaction:

Concomitant use of Eszopiclone with other CNS depressants including antihistamines, antidepressants, opioids, sedative or hypnotics & antipsychotics may increase the risk of CNS depression. Drugs that inhibit the CYP3A4 enzyme system, such as ketoconazole, itraconazole, clarithromycin, nefazodone, ritonavir, nelfinavir & rifampicin may reduce the effectiveness of Eszopiclone.

Overdosage:

Symptoms of overdosage may include sleepiness, confusion, dizziness, severe drowsiness, difficult or slow breathing, unconsciousness and coma. If overdosage is suspected, contact to doctor immediately.

Storage:

Store at room temperature, keep away from heat & light. Keep out of the reach of children.

Packing:

Sleepil 1 tablet: Each box contains  5×10`s tablets in blister pack.

Sleepil 2 tablet: Each box contains 3×10`s tablets in blister pack.