Ramelteon (patient information)

IMPORTANT WARNING:

[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.

Why is this medication prescribed

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.

How should this medicine be used

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.

Other uses for this medicine

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

What special precautions should I follow

See the MedWatch notification at the beginning of the monograph.

Before taking ramelteon:

• 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.

What special dietary instructions should I follow

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

What should I do if I forget a dose

Do not take a double dose to make up for a missed one.

Side effects

See the MedWatch notification at the beginning of the monograph.

Mild side effects

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

Severe side effects

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/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

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 emergency/overdose

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.

What other information should I know

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.

Brand names

• Rozerem®