Eszopiclone (By mouth)

Introduction

Eszopiclone (es-zoe-PIK-lone)

Treats insomnia (sleep disorder).

Brand Name(s)

Lunesta

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• Do not take this medicine with or immediately after a heavy meal.
• Swallow the tablet whole. Do not crush, break, or chew it.
• This medicine works quickly. Do not take your medicine until right before you go to bed. Some people might need to wait until they are in bed to take the medicine.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• This medicine should be used only when you cannot sleep. You should not need a regular dosage schedule.
• You should not use two doses at the same time. Give the drug enough time to work.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using nefazodone (Serzone®), rifampin (Rifadin®), an antibiotic medicine (such as clarithromycin, troleandomycin, Biaxin®, or Tao®), medicine to treat a fungus infection (such as fluconazole, itraconazole, ketoconazole, Diflucan®, Nizoral®, or Sporanox®), medicine to treat HIV or AIDS (such as nelfinavir, ritonavir, Kaletra®, Norvir®, or Viracept®), or seizure medicine (such as Depakote®, Dilantin®, Luminal®, or Tegretol®).
• Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, lung disease, depression or anxiety problems, or if you have a history of alcohol or drug problems.
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have itching, hives, trouble breathing, or any swelling of your hands, face, or mouth when you take this medicine.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. This medicine may also cause sleep-related behaviors such as driving a car (sleep-driving), walking (sleep-walking), having sex, making phone calls, or preparing and eating food while asleep or not fully awake. If these reactions occur, tell your doctor right away.
• This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions. If you continue to have problems sleeping, check with your doctor.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
• If your symptoms do not improve or if they get worse, call your doctor.
• Older adults and children may be more sensitive to side effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Abnormal thinking and behavior.
• Anxiety, aggressiveness, confusion, depression, or dizziness.
• Burning while urinating.
• Change in how much or how often you urinate.
• Fever, chills, cough, sore throat, and body aches.
• Lightheadedness or fainting.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Rapid weight gain, swelling in your hands, ankles, or feet.
• Seeing, hearing, or feeling things that are not there.
• Severe diarrhea.
• Severe pain or bleeding during menstruation.
• Thoughts about hurting oneself or others.

If you notice these less serious side effects, talk with your doctor:

• Altered or bad taste.
• Decreased interest in having sex.
• Depression (sadness) or agitation.
• Difficulty in coordination.
• Dry mouth, nausea, or increased thirst.
• Enlargement of breasts in males.
• Headache.
• Memory loss.
• Rash or redness on your skin.
• Swelling, stiffness, or pain in your joints.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088