Drugs & Vitamins

Active Ingredients: Ramelteon
Other Names: Rozerem
Drug Class: Miscellaneous Sedatives and Hypnotics
Rx Status: Available by prescription only
Generic Available: No
Product Images & Descriptions:

What is/are Ramelteon ? (Back to top)
RAMELTEON is used to treat insomnia. This medicine helps you to fall asleep. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care providers before I take this medicine? (Back to top)
They need to know if you have any of these conditions:

• depression
• history of a drug or alcohol abuse problem
• liver disease
• lung or breathing disease
• suicidal thoughts
• an unusual or allergic reaction to ramelteon, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine? (Back to top)
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. It is better to take this medicine on an empty stomach and only when you are ready for bed. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

Note: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose? (Back to top)
This does not apply. This medicine should only be taken immediately before going to sleep. Do not take double or extra doses.

What may interact with this medicine? (Back to top)
Do not take this medicine with any of the following:

• fluvoxamine
• melatonin

• medicines used to treat fungal infections like ketoconazole, fluconazole, or itraconazole
• rifampin

This list may not describe all possible interactions. Give your health care providers a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What side effects may I notice from this medicine? (Back to top)
Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breast milk production or discharge
• breathing problems
• joint or muscle pain
• depression, suicidal thoughts
• missed monthly period (for women)
• unusual activities while asleep like driving, eating, making phone calls
• unusually weak or tired
• worsening of insomnia

• bad taste
• daytime sleepiness
• decreased sex drive
• diarrhea
• headache
• nausea

This list may not describe all possible side effects.

What should I watch for while using this medicine? (Back to top)
Visit your doctor or health care professional for regular checks on your progress. If your condition gets worse after you start taking this medicine or you notice any different emotions or behaviors (like anxiety, depression, excessive excitement, or mania), you should contact your health care provider right away.

Do not take this medicine unless you are able to get a full night's sleep before you must be active again. You may not be able to remember things that you do in the hours after you take this medicine. Some people have reported driving, making phone calls, or preparing and eating food while asleep after taking sleep medicine. Take this medicine right before going to sleep. Tell your doctor if you are have any problems with your memory.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Where should I keep this medicine? (Back to top)
Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep the container tightly closed. Protect from moisture and humidity. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Last Updated:March 19, 2007

COPYRIGHT© Gold Standard, An Elsevier Company