Eszopiclone

Eszopiclone is a prescription medicine used to treat insomnia. It reduces sleep onset time and frequent awakening at night. This medicine improves sleep maintenance and therefore ensures sound sleep.

Eszopiclone belongs to a group of medicines called sedative-hypnotics. It works by slowing activity of the nerve cells in the brain and helps fall asleep.

• Insomnia: Indicated for the management of insomnia, including difficulty in falling asleep, difficulty in maintaining sleep during the night, and waking up too early in the morning.

Non-benzodiazepine Hypnotic

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.

Eszopiclone is a nonbenzodiazepine hypnotic. The exact mechanism of action is unknown, its effect is associated with the interaction with GABA-receptor complex.

Adult Dose:

• Insomnia (18-64 years): 2 mg immediately before bedtime; may increase to 3 mg if clinically indicated.
• Elderly (>=65 years, difficulty falling asleep): 1 mg; may increase to 2 mg if needed.
• Elderly (difficulty staying asleep): 2 mg.
• Severe hepatic impairment: Max: 2 mg daily.

Child Dose: Safety and efficacy not established.

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Eszopiclone is to be taken on an empty stomach.

If you miss a dose of Eszopiclone, please consult your doctor.

Drug Interactions:

• CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, nefazodone, ritonavir, nelfinavir): May increase plasma concentrations; dosage reduction may be needed.
• CYP3A4 inducers (rifampicin): May reduce concentrations.
• Alcohol, anticonvulsants, antihistamines, psychotropic drugs: May enhance adverse CNS effects.
• Flumazenil: May diminish sedative effect.

Food Interactions: It is unsafe to consume alcohol with Eszopiclone. Alcohol may enhance sedative effects.

Contraindications:

• Hypersensitivity
• Depression (caution)
• Severe Chronic Obstructive Lung Disease
• Severe Liver Disease
• Weakened Patient
• Having thoughts of Suicide

Common Side Effects:

• Sleepiness
• Dizziness
• Headache
• Taste change
• Dryness in mouth
• Rash
• Anxiety
• Hallucination
• Respiratory tract infection
• Viral infection
• Difficulty with coordination

Use in Pregnancy: Category C. Animal studies have shown harmful effects on the developing baby. Should be used only if potential benefit justifies potential risk to the fetus.

Use in Lactation: Eszopiclone is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby. Monitor baby for excessive sleepiness.

Precautions:

• Eszopiclone may impair alertness and motor coordination; risk of morning impairment increases with dose.
• Take on an empty stomach (high-fat meal reduces absorption and effect).
• Take 30-45 minutes before bedtime and only when you have time to sleep for at least 7 hours.
• It makes you feel dizzy next morning; don't drive or do anything requiring concentration.
• Inform your doctor if sleep doesn't improve after 7-10 days.
• Stop taking and inform doctor if sleep driving or memory loss occurs.
• Inform doctor if behavioral changes, new or worsening depression or suicidal thoughts occur.
• Do not stop taking suddenly (may lead to anxiety, mood changes, restlessness).

Pediatric Use: Pediatric dosing is not available.

Geriatric Use: Elderly dose: difficulty falling asleep: 1 mg, may increase to 2 mg; difficulty staying asleep: 2 mg.

Renal Impairment: Safe to use in patients with kidney disease; no dose adjustment recommended.

Hepatic Impairment: Use with caution in severe liver disease; dose adjustment may be needed; mild-moderate liver disease: no dose adjustment recommended.

Overdose: Limited pre-marketing clinical experience. One case of overdose with up to 36 mg reported where subject fully recovered.

Miscellaneous sedatives and hypnotics

Storage: Keep below 30 degree C temperature, away from light and moisture. Keep out of reach of children.

Eszopiclone