RAMELTEON (Systemic)?
Some commonly used brand names are:
In the U.S.?
? Not commercially available in Canada.
Category
Description
Ramelteon (ram-EL-tee-on) belongs tothe group of medicines called central nervous system (CNS) depressants (medicinesthat slow down the nervous system). Ramelteon is used to treat insomnia (troublein sleeping). Ramelteon helps you get to sleep faster and sleep through thenight. In general, when sleep medicines are used every night for a long time,they may lose their effectiveness. In most cases, sleep medicines should beused only for short periods of time, such as 1 or 2 days, and generally forno longer than 1 or 2 weeks.
This medicine is available only with your doctor's prescription, in thefollowing dosage forms:
Before Using This Medicine
In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For ramelteon, the followingshould be considered:
Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to ramelteon. Also tell your doctor and pharmacist ifyou are allergic to any other substances, such as foods, preservatives, ordyes.
Pregnancy?Ramelteon has not been studied in pregnant women.However, studies in pregnant animals have shown that ramelteon slows downthe development of the offspring when given to the mother in doses many timesthe human dose. Before taking this medicine, make sure your doctor knows ifyou are pregnant or if you may become pregnant.
Breast-feeding?Ramelteon passes into the milk of rats. It isnot known whether it passes into human milk. The use of ramelteon in nursingmothers is not recommended.
Children?Studies on this medicine have been done only inadult patients, and there is no specific information comparing use of ramelteonin children with use in other age groups.
Older adults?This medicine has been tested and has not beenshown to cause different side effects or problems in older people than itdoes in younger adults.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingramelteon, it is especially important that your doctor and pharmacist knowif you are taking any of the following:
- Alcohol?May increase the side effects of ramelteon
- CYP inducers (Rifampin [e.g., Rifadin, Rimactane])?May decreasethe effectiveness of ramelteon
- CYP1A2 inhibitors (Fluvoxamine [e.g., Luvox]) or
- CYP3A4 inhibitors (Ketoconazole [e.g., [Nizoral])?May increasethe amount of ramelteon in you body and increase your chance for side effectsfrom ramelteon
Other medical problems?The presence of other medicalproblems may affect the use of ramelteon. Make sure you tell your doctor ifyou 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)?Ramelteonmay 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 moreof it, do not take it more often, and do not take it for a longer time thanyour 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 exactlyas directed.
Dosing?The dose of ramelteon will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage 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 themissed 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 otherdamp places. Heat or moisture may cause the medicine to break down.
- Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
Insomniathat lasts following a reasonable period of treatment may be a sign of anothermedical problem that should be evaluated.Consult yourdoctor 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 aretaking ramelteon, be sure to discuss it with your doctor. Some changes thathave occurred in people taking this medicine are like those seen in peoplewho drink alcohol and then act in a manner that is not normal. Other changesmay be more unusual and extreme, such as confusion, worsening of depression,hallucinations (seeing, hearing, or feeling things that are not there), suicidalthoughts, and unusual excitement, nervousness, or irritability.
This medicine may cause some people to become drowsy, dizzy, or less alertthan they are normally. Make sure you know how you reactto this medicine before you drive, use machines, or do anything else thatcould be dangerous if you are dizzy or are not alert.
If cessation of menstrual cycle (females), decreased libido, or problemswith fertility occur, be sure to discuss it with your doctor.
Side Effects of This Medicine
Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.
Other side effects may occur that usuallydo not need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome.
Less common
Body aches or pain; change in taste; chills; cough; difficulty in breathing; difficultyin 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; runnynose; shivering; sleeplessness; sneezing, or sore throat; sore throat; sweating; swollen joints; trouble concentrating; trouble sleeping; unable to sleep; unusual tiredness or weakness; vomiting
Otherside effects not listed above may also occur in some patients. If you noticeany other effects, check with your doctor.
Developed: 09/14/2005
