Ramelteon
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Ramelteon
(ram el' tee on)
(ram el' tee on)
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Rozerem
[Posted 03/14/2007] FDA notified healthcare professionals of its request that all manufacturers of sedative-hypnotic drug
products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language
concerning potential risks. These risks include severe allergic reactions and complex sleep-related behaviors, which may include
sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with
no memory of the event. FDA also requested that each product manufacturer send letters to health care providers to notify
them about the new warnings, and that manufacturers develop Patient Medication Guides for the products to inform consumers
about risks and advise them of potential precautions that can be taken. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Sedative and http://www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html.
See the MedWatch notification at the beginning of the monograph.
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.
See the MedWatch notification at the beginning of the monograph.
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 high fat 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.
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.
Your insomnia should improve after you begin treatment with ramelteon. Call your doctor if your insomnia does not improve
at the beginning of your treatment. Also call your doctor if your insomnia gets worse or you notice unusual changes in your
behavior at any time during your treatment.
See the MedWatch notification at the beginning of the monograph.
Ramelteon may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- drowsiness or tiredness
- dizziness
- upset stomach
- changes in the way food tastes
- muscle or joint pain
- stuffy or runny nose, cough, or other cold symptoms
- flu-like symptoms
Some side effects can be serious. If you experience any of these symptoms, call your doctor:
- stopping of menstrual periods
- milky discharge from the nipples
- decreased sexual desire
- fertility problems
- depression
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 [at http://www.fda.gov/MedWatch/index.html] or by phone at 1-800-332-1088.
See the MedWatch notification at the beginning of the monograph.
- tell your doctor and pharmacist if you are allergic to ramelteon or any other medications.
- tell your doctor and pharmacist what 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: amiodarone (Cordarone, Pacerone);certain antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); aprepitant (Emend); cimetidine (Tagamet); clarithromycin (Biaxin, in Prevpac); clopidogrel (Plavix);efavirenz (Sustiva); HIV protease inhibitors including atazanavir (Reyataz), indinavir (Crixivan), lopinavir (in Kaletra),nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase); fluoroquinolone antibiotics including ciprofloxacin (Cipro), gatifloxacin (Tequin), levofloxacin (Levaquin), norfloxacin (Noroxin), ofloxacin (Floxin), others; fluvastatin (Lescol) fluvoxamine (Luvox); metronidazole (Flagyl);nefazodone; rifampin (Rifadin, Rimactane);sulfamethoxazole (Bactrim, Septra); sulfinpyrazone (Anturane); ticlopidine (Ticlid) ; and zarfirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had chronic obstructive pulmonary disease (COPD, damage to the lungs that makes breathing difficult), sleep apnea (breathing stops for a short time during sleep), depression, 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.
- ask your doctor about the safe use of alcoholic beverages while you are taking ramelteon. Alcohol can add to the drowsiness caused by ramelteon.
Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.
Do not take a double dose to make up for a missed one.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
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). Throw away any medication that is outdated or no longer needed.
Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing,
call local emergency services at 911.
See the MedWatch notification at the beginning of the monograph.
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.
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