AUDIENCE:Patient, Health Professional, Pharmacy
ISSUE:FDAis advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths. These behaviors appear to be more common with
than other prescription medicines used for sleep.
BACKGROUND:Eszopiclone, zaleplon, and zolpidem are medicines used to treat insomnia in adults who have difficulty falling asleep or staying asleep. They are in a class of medicines called sedative-hypnotics and have been approved and on the market for many years. These insomnia medicines work by slowing activity in the brain to allow sleep. Quality sleep can have a positive impact on physical and mental health.
If patients experience a complex sleep behavior where you engage in activities while you are not fully awake or if you do not remember activities you have done while taking the medicine you should:
Healthcare professionals should not prescribe eszopiclone, zaleplon, or zolpidem to patients who have previously experienced complex sleep behaviors after taking any of these medicines. Healthcare Professionals should advise all patients that:
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.
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 7 to 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 your 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.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking eszopiclone,
Talk to your doctor about drinking grapefruit juice while taking this medication.
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 7 to 8 hours afterward.
Eszopiclone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment:
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 ( Web Site ) or by phone (1-800-332-1088).
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).
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. Web Site
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( Web Site) for more information if you do not have access to a take-back program.
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include the following:
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, 2019.