(ram el' tee on)

Brand Name(s): Rozerem^®; also available generically

WHY is this medicine prescribed?

Ramelteon is used to help patients who have sleep-onset insomnia (difficulty falling asleep) fall asleep more quickly. Ramelteon is in a class of medications called melatonin receptor agonists. It works similarly to melatonin, a natural substance in the brain that is needed for sleep.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Ramelteon comes as a tablet to take by mouth. It is usually taken once a day, no earlier than 30 minutes before bedtime. Do not take ramelteon with or shortly after a meal. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ramelteon exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

You may become sleepy soon after you take ramelteon. After you take ramelteon, you should complete any necessary bedtime preparations and go to bed. Do not plan any other activities for this time. Do not take ramelteon if you will be unable to remain asleep for 7 to 8 hours after taking the medication.

Your insomnia should improve within 7 to 10 days after you begin treatment with ramelteon. Call your doctor if your insomnia does not improve during this time or gets worse at any time during your treatment.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ramelteon 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 (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before taking ramelteon,

• tell your doctor and pharmacist if you are allergic to ramelteon, any other medications, or any of the ingredients in ramelteon tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor if you are taking fluvoxamine (Luvox). Your doctor will probably tell you not to take ramelteon while you are taking this medication.

• tell your doctor and pharmacist what other 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: certain antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); cimetidine (Tagamet); clarithromycin (Biaxin, in Prevpac); fluoroquinolones including ciprofloxacin (Cipro, Proquin XR), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), others; HIV protease inhibitors including indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); medications for anxiety, pain or seizures; nefazodone; rifampin (Rifadin, in Rifamate, in Rifater, Rimactane); sedatives; other sleeping pills; ticlopidine (Ticlid); and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with ramelteon, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have ever thought about killing yourself or planned or tried to do so, and if you have or have ever had chronic obstructive pulmonary disease (COPD, damage to the lungs that makes breathing difficult) or other lung disease, sleep apnea (condition in which you briefly stop breathing many times during the night) or other breathing problems, depression, mental illness, or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking ramelteon, call your doctor.

• you should know that ramelteon 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 during your treatment with ramelteon. Alcohol can make the side effects of ramelteon worse.

• you should know that some people who took ramelteon 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. It is hard to tell if these changes are caused by ramelteon or if they are caused by physical or mental illnesses that you already have or suddenly develop. Tell your doctor right away if you experience any of the following symptoms: agitation, anxiety, frenzied or abnormally excited mood, hallucinations (seeing things or hearing voices that do not exist), nightmares, memory problems, new or worsening depression, thinking about or trying to kill yourself, and any other changes in your usual thoughts, mood, 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 eating grapefruit and drinking grapefruit juice while taking this medication.

What should I do IF I FORGET to take a dose?

Ramelteon should only be taken at bedtime. If you did not take ramelteon at bedtime and you are unable to fall asleep, you may take ramelteon if you will be able to remain in bed for 7 to 8 hours afterward. Do not take ramelteon if you are not ready to go to sleep and stay asleep for at least 7 to 8 hours.

What SIDE EFFECTS can this medicine cause?

Ramelteon may cause side effects. Tell your doctor if either of these symptoms are severe or do not go away:

• drowsiness or tiredness
• dizziness

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• swelling of the tongue or throat
• difficulty swallowing or breathing
• feeling that the throat is closing
• nausea
• vomiting
• irregular or missed menstrual periods
• milky discharge from the nipples
• decreased sexual desire
• fertility problems

Ramelteon 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 (http://www.fda.gov/Safety/MedWatch) 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).

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. http://www.upandaway.org

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 (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: April 15, 2019.