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Eszopiclone is indicated for the treatment of insomnia, including difficulty falling asleep and difficulty maintaining sleep through the night. Eszopiclone is the first sedative approved long-term use.

Therapeutic Class

Miscellaneous sedatives & hypnotics

Pharmacology

Eszopiclone may interact with Gama-aminobutyric acid (GABA) receptor complexes at binding domains located close to or allosterically coupled to benzodiazepine receptors.

Dosage & Administration

The usual dose to improve or maintain sleep in most adults is 2 or 3 mg. Persons over the age of 65 years usually are treated with 1 or 2 mg. Eszopiclone should be taken immediately before going to bed since the onset of sedation may occur as rapidly as 10 minutes.

It should be taken only by individuals who intend to sleep for at least 8 hours since its effects may last up to six hours.

Interaction

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

Contraindications

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

Side Effects

Dizziness, dry mouth, unpleasant taste, or difficulty with coordination may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To reduce the risk of dizziness or falling, get up slowly when rising from a sitting or lying position.

This medication may make you sleepy during the day. Tell your doctor if you have daytime drowsiness. Your dose may need to be adjusted.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: memory loss, mental/mood/behavior changes (such as new/worsening depression, abnormal thoughts, thoughts of suicide, hallucinations, confusion, agitation, aggressive behavior, anxiety).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Pregnancy & Lactation

Pregnancy: Category C. There is no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.

Nursing Mothers: It is not known whether the drug is excreted in breast milk. As many drugs are excreted in breast milk, caution should be exercised when Eszopiclone is administered to a nursing mother.

Precautions & Warnings

Before taking eszopiclone, tell your doctor or pharmacist if you are allergic to it; or to zopiclone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, lung/breathing problems (such as chronic obstructive pulmonary disease-COPD, sleep apnea),

mental/mood problems (such as depression, thoughts of suicide), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), personal or family history of sleepwalking, a certain muscle disease (myasthenia gravis).

The effects of this drug can last even after you wake up the next day. If you did not get 7 to 8 hours of sleep or took other medications that made you sleepy or are more sensitive to this drug, you may feel alert but not think clearly enough to drive.

Alcohol or marijuana (cannabis) can also make you more sleepy. Wait at least 8 hours after taking this drug before driving, and do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages.

Talk to your doctor if you are using marijuana (cannabis). If you take the 3-milligram dosage of eszopiclone, do not drive, use machinery, or do anything that needs alertness the next day.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially dizziness, confusion, unsteadiness, and excessive drowsiness. These side effects can increase the risk of falling. Also see the How to Use section.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. Infants born to mothers who take this medication near the time of delivery may have undesirable effects such as excessive sleepiness. Tell your doctor if you notice such effects in your newborn.

Overdose Effects

There is limited clinical experience with the overdose of Eszopiclone. In clinical trials one case of overdose with up to 36 mg of Eszopiclone has been reported in which the subject fully recovered. Intravenous fluids should be administered as needed & Flumazenil may be useful.

Storage Conditions

Store at 25°C.