Lunesta (Eszopiclone) is a sedative, also called a hypnotic. It affects chemicals in your brain that may be unbalanced in people with sleep problems (insomnia).

Indications and Usage

Lunesta (eszopiclone) is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, Lunesta administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).

Take Lunesta exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets. Eszopiclone may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law. Lunesta will make you fall asleep. Never take this medicine during your normal waking hours, unless you have at least 7 to 8 hours to dedicate to sleeping. Call your doctor if your symptoms do not improve after 7 to 10 days of treatment, or if they get worse. Do not stop using Lunesta suddenly after taking it over several days in a row, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine. Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription. Insomnia symptoms may also return after you stop taking Lunesta, and may be even worse than before. Tell your doctor if you still have worsened insomnia after the first few nights without taking Lunesta.

What form(s) does this medication come in?

Lunesta is available in 1 mg, 2 mg and 3 mg strengths for oral administration.

Lunesta 3 mg tablets are round, dark blue, film-coated, and identified with debossed markings of S193 on one side.

Lunesta 2 mg tablets are round, white, film-coated, and identified with debossed markings of S191 on one side.

Lunesta 1 mg tablets are round, light blue, film-coated, and identified with debossed markings of S190 on one side.

Dosage and Administration

The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or 3 mg if clinically indicated. In some patients, the higher morning blood levels of Lunesta following use of the 2 mg or 3 mg dose increase the risk of next day impairment of driving and other activities that require full alertness. The total dose of Lunesta should not exceed 3 mg, once daily immediately before bedtime. The total dose of Lunesta should not exceed 2 mg in elderly or debilitated patients. Taking Lunesta with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of Lunesta on sleep latency.

Precautions

Before taking eszopiclone, tell your doctor or pharmacist if you are allergic to it, or zopiclone. Or if you have any other allergies. This product may contain inactive ingredients, which can cause allergies or other problems. For more information, talk to your pharmacist.

Before using this medication, tell your doctor or pharmacist your medical history, especially: kidney disease, liver disease, lung / respiratory problems (such as chronic obstructive pulmonary disease – chronic obstructive pulmonary disease, sleep apnea), and mental / mood problems (such as depression, thoughts of suicide), a personal or family history of substance use disorder (such as excessive drug/alcohol use or addiction), a personal or family history of sleepwalking and certain muscle diseases (myasthenia gravis).

The effects of this medicine may persist even after waking up the next day. If you don’t sleep 7 to 8 hours or take other medications that make you feel sleepy or more sensitive to this medication, you may feel awake but not think clearly enough to drive. Marijuana or alcohol can make you more sleepy.

Wait at least 8 hours after taking this medication before driving, and do not drive, use machines, or do anything that you should be aware of until you can do so safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). If you take a 3-milligram dose of eszopiclone, do not drive, use machinery, or do anything that requires alertness the next day.

Before surgery, tell your doctor or dentist about all the products you use (including prescription and over-the-counter medications and herbal products).

Older adults may be more sensitive to the side effects of this medication, especially dizziness, confusion, instability, and excessive drowsiness. These side effects can increase your risk of falling.

This medication should be used only when clearly necessary during pregnancy. Discuss the risks and benefits with your doctor. Babies born to mothers who take this drug near the time of birth can have unwanted effects, such as excessive drowsiness. Tell your doctor if you notice such effects in newborns.

It is not known whether this drug passes into breast milk. However, similar medications pass into breast milk. Consult your doctor before breastfeeding.

Side Effects

Lunesta is usually effective in treating insomnia, but it may also cause some unwanted side effects. Some of these may include dry mouth, dizziness, unpleasant taste, or difficulty with coordination. If you experience these side effects and they persist or worsen, you should contact your doctor immediately.

Inform your doctor right away if you experience serious side effects such as memory loss, depression, thoughts of suicide, confusion, agitation, headaches, or hallucinations. Allergic reactions to Lunesta are rare. However, seek immediate medical attention if you experience signs of an allergic reaction such as itching, rashes, severe dizziness, or trouble breathing.

This is not a complete list of side effects. Others not listed here may also occur while you are taking this medication. Check with your healthcare provider for medical advice on Lunesta to ensure you're aware of all the risks and benefits.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. A product that may interact with this drug is: sodium oxybate. Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. Eszopiclone is very similar to zopiclone. Do not use medications containing zopiclone while using eszopiclone.

Warning

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. During pregnancy, this medication should be used only when clearly needed. 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. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding.