[Posted 05/15/2014]ISSUE:FDA has notified health professionals and their medical care organizations of a new warning that the insomnia drug eszopiclone (Lunesta) can cause next-day impairment of driving and other activities that require alertness. FDA recommends a decreased starting dose of eszopiclone to 1 mg at bedtime. Women and men are equally susceptible to impairment from eszopiclone, so the recommended starting dose of 1 mg is the same for both. FDA approved changes to the eszopiclone prescribing information and the patient Medication Guide to include these new recommendations. The drug labels for generic eszopiclone products will also be updated to include these changes.
BACKGROUND:A study of eszopiclone found that the previously recommended dose of 3 mg can cause impairment to driving skills, memory, and coordination that can last more than 11 hours after receiving an evening dose (see Data Summary). Despite these driving and other problems, patients were often unaware they were impaired. The new lower recommended starting dose of 1 mg at bedtime will result in less drug in the blood the next day.
RECOMMENDATION:Health care professionals should follow the new dosing recommendations when starting patients on eszopiclone. Patients should continue taking their prescribed dose of eszopiclone and contact their health care professionals to ask about the most appropriate dose for them. FDA is continuing to evaluate the risk of impaired mental alertness with the entire class of sleep aid drugs, including over-the-counter drugs available without a prescription, and will update the public as new information becomes available. For more information visit the FDA website at: Web Siteand Web Site.
WHY is this medicine prescribed?
Eszopiclone is used to treat insomnia (difficulty falling asleep or staying asleep). Eszopiclone is in a class of medications called hypnotics. It works by slowing activity in the brain to allow sleep.
HOW should this medicine be used?
Eszopiclone comes as a tablet to take by mouth. It is usually taken once a day at bedtime or after unsuccessfully trying to fall asleep. Do not take eszopiclone with or shortly after a heavy, high-fat meal. Eszopiclone may not work well if it is taken with high fat foods. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take eszopiclone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
You will probably become very sleepy soon after you take eszopiclone and will remain sleepy for some time after you take the medication. You should only take eszopiclone immediately before you go to bed or after you have gone to bed and have been unable to fall asleep. Only take eszopiclone if you will be able to stay in bed for at least 8 hours after taking the medication. If you do not go to bed right after you take eszopiclone or if you get up too soon after taking eszopiclone, you may experience dizziness, lightheadedness, hallucinations (seeing things or hearing voices that do not exist), and problems with coordination and memory.
Your doctor may change your dose of eszopiclone during your treatment. Your doctor may increase your dose to help you sleep better or decrease your dose if you are too drowsy during the daytime.
You should be sleeping well within 7 to 10 days after you start taking eszopiclone. Call you doctor if your sleep problems do not improve during this time, if they get worse at any time during your treatment, or if you notice any changes in your thoughts or behavior.
Do not stop taking eszopiclone without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking eszopiclone you may experience withdrawal symptoms such as anxiety, unusual dreams, stomach and muscle cramps,nausea, vomiting, sweating, shakiness, and rarely, seizures.
After you stop taking eszopiclone, you may have more difficulty falling asleep and staying asleep than you did before you took the medication. These sleep problems are normal and usually get better without treatment after one or two nights.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with eszopiclone and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking eszopiclone,
- tell your doctor and pharmacist if you are allergic to eszopiclone or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants; certain antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); antihistamines; clarithromycin (Biaxin); certain HIV protease inhibitors such as nelfinavir (Viracept) and ritonavir (Norvir); medications for anxiety, mental illness, or seizures; nefazodone; olanzapine (Zyprexa); rifampin (Rifadin, Rimactane); sedatives; other sleeping pills; tranquilizers; and troleandomycin (TAO) (not available in the US). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you drink or have ever drunk large amounts of alcohol and if you use or have ever used street drugs or have overused prescription medications. Also tell your doctor if you have ever thought about killing yourself or tried to do so and if you have or have ever had depression, mental illness, lung disease or breathing problems, or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking eszopiclone, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking eszopiclone.
- you should know that eszopiclone may make you drowsy during the daytime. Do not drive a car or operate machinery until you know how this medication affects you.
- do not drink alcohol while you are taking eszopiclone. Alcohol can make the side effects from eszopiclone worse.
- you should know that some people who took medications for sleep got out of bed and drove their cars, prepared and ate food, had sex, made phone calls, or were involved in other activities while partially asleep.After they woke up, these people were usually unable to remember what they had done. Call your doctor right away if you find out that you have been driving or doing anything else unusual while you were sleeping.
- you should know that your mental health may change in unexpected ways while you are taking this medication. These changes may be caused by eszopiclone or they may be caused by physical or mental illnesses that you already have or that you develop during your treatment. Tell your doctor right away if you experience any of the following symptoms: aggressiveness, strange or unusually outgoing behavior, hallucinations (seeing things or hearing voices that do not exist), feeling as if you are outside of your body, memory problems, new or worsening depression, thinking about killing yourself, confusion, and any other changes in your usual thoughts or behavior. Be sure that your family knows which symptoms may be serious so that they can call the doctor if you are unable to seek treatment on your own.
What SPECIAL DIETARY instructions should I follow?
Talk to your doctor about drinking grapefruit juice while taking this medication
What should I do IF I FORGET to take a dose?
Eszopiclone should only be taken at bedtime. If you did not take eszopiclone before you went to bed and you are unable to fall asleep, you may take eszopiclone if you will be able to stay in bed for at least 8 hours afterward. Do not take a double dose of eszopiclone to make up for a missed dose.
What SIDE EFFECTS can this medicine cause?
Eszopiclone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- daytime drowsiness
- loss of coordination
- unpleasant taste
- dry mouth
- unusual dreams
- decreased sexual desire
- painful menstrual periods
- breast enlargement in males
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
- swelling of the eyes, face, lips, tongue, throat, hands, feet, ankles, or lower legs
- difficulty breathing or swallowing
- feeling that the throat is closing
Eszopiclone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- coma (loss of consciousness for a period of time)
What OTHER INFORMATION should I know?
Keep all appointments with your doctor.
Do not let anyone else take your medication. Eszopiclone is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: May 15, 2014.