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RAMELTEON (Systemic)

Some commonly used brand names are:

In the U.S.—

  • Rozerem

Not commercially available in Canada.


  • Sedative-hypnotic


Ramelteon (ram-EL-tee-on) belongs to the group of medicines called central nervous system (CNS) depressants (medicines that slow down the nervous system). Ramelteon is used to treat insomnia (trouble in sleeping). Ramelteon helps you get to sleep faster and sleep through the night. In general, when sleep medicines are used every night for a long time, they may lose their effectiveness. In most cases, sleep medicines should be used only for short periods of time, such as 1 or 2 days, and generally for no longer than 1 or 2 weeks.

This medicine is available only with your doctor"s prescription, in the following dosage forms:

  • Oral
  • Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ramelteon, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to ramelteon. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Ramelteon has not been studied in pregnant women. However, studies in pregnant animals have shown that ramelteon slows down the development of the offspring when given to the mother in doses many times the human dose. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Ramelteon passes into the milk of rats. It is not known whether it passes into human milk. The use of ramelteon in nursing mothers is not recommended.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of ramelteon in children with use in other age groups.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking ramelteon, it is especially important that your doctor and pharmacist know if you are taking any of the following:

  • Alcohol—May increase the side effects of ramelteon
  • CYP inducers (Rifampin [e.g., Rifadin, Rimactane])—May decrease the effectiveness of ramelteon
  • CYP1A2 inhibitors (Fluvoxamine [e.g., Luvox]) or
  • CYP3A4 inhibitors (Ketoconazole [e.g., [Nizoral])—May increase the amount of ramelteon in you body and increase your chance for side effects from ramelteon

Other medical problems—The presence of other medical problems may affect the use of ramelteon. Make sure you tell your doctor if you have any other medical problems, especially:

  • Emphysema, asthma, bronchitis, or other chronic lung disease or
  • Mental depression or
  • Sleep apnea (temporary stopping of breathing during sleep)—Ramelteon may make these conditions worse.
  • Liver disease—Higher blood levels of ramelteon may result, increasing the chance of side effects.

Proper Use of This Medicine

Take this medicine only as directed by your doctor . Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Take ramelteon just before going to bed, when you are ready to go to sleep. This medicine works very quickly to put you to sleep.

Take ramelteon on an empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

Dosing—The dose of ramelteon will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of ramelteon. If your dose is different, do not change it unless your doctor tells you to do so.

  • For oral dosage form (tablets):
    • For the treatment of insomnia (trouble in sleeping):
      • Adults—8 milligrams (mg) at bedtime.
      • Children—Use and dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

  • Keep out of the reach of children.
  • Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
  • Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Insomnia that lasts following a reasonable period of treatment may be a sign of another medical problem that should be evaluated.Consult your doctor if new or worsening signs of insomnia occur.

Avoid drinking alcohol while using this medicine. Ramelteon will add to the effects of alcohol.

If you develop any unusual and strange thoughts or behavior while you are taking ramelteon, be sure to discuss it with your doctor. Some changes that have occurred in people taking this medicine are like those seen in people who drink alcohol and then act in a manner that is not normal. Other changes may be more unusual and extreme, such as confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert .

If cessation of menstrual cycle (females), decreased libido, or problems with fertility occur, be sure to discuss it with your doctor.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

More common

Dizziness; sleepiness or unusual drowsiness

Less common

Body aches or pain; change in taste; chills; cough; difficulty in breathing; difficulty in moving; discouragement; ear congestion; fatigue; feeling sad or empty; fever; general feeling of discomfort or illness; irritability; joint pain; loss of appetite; loss of interest or pleasure; loss of taste; loss of voice; muscle aching or cramping; muscle pain or stiffness; nasal congestion; nausea; pain in joints; runny nose; shivering; sleeplessness; sneezing, or sore throat; sore throat; sweating; swollen joints; trouble concentrating; trouble sleeping; unable to sleep; unusual tiredness or weakness; vomiting

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 09/14/2005

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Typical mistypes for Ramelteon
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