Rozerem

Generic Name: ramelteon (ram EL tee on)

Brand Names: Rozerem

What is ramelteon?

Ramelteon is a sedative, also called a hypnotic. It works by affecting certain substances in your body that help regulate your "sleep-wake cycle."

Ramelteon is used to treat insomnia that is associated with having trouble falling asleep.

Unlike some other sleep medications, ramelteon is not known to be habit-forming.

Ramelteon may also be used for purposes not listed in this medication guide.

What is the most important information I should know about ramelteon?

You should not use this medication if you are allergic to ramelteon, or if you have severe liver disease.

You should not take ramelteon if you are also taking the antidepressant fluvoxamine (Luvox).

Before taking ramelteon, tell your doctor if you have liver disease, sleep apnea, a breathing disorder such as chronic obstructive pulmonary disease, or a history of depression, mental illness, or suicidal thoughts.

Take ramelteon 30 minutes before your normal bedtime. After you take ramelteon, avoid doing anything other than getting ready for bed.

Avoid taking ramelteon together with or just after eating a high-fat meal. This will make it harder for your body to absorb the medication.

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking ramelteon and talk with your doctor about another treatment for your sleep disorder.

What should I discuss with my healthcare provider before taking ramelteon?

You should not use this medication if you are allergic to ramelteon, or if you have severe liver disease.

You should not take ramelteon if you are also taking the antidepressant fluvoxamine (Luvox).

To make sure you can safely take ramelteon, tell your doctor if you have any of these other conditions:

• liver disease;


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  sleep apnea (breathing stops while you are asleep);

  
  


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  a breathing disorder such as chronic obstructive pulmonary disease (COPD); or

  
  


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  a history of depression, mental illness, or suicidal thoughts.

  
  

FDA pregnancy category C. It is not known whether ramelteon will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether ramelteon passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Ramelteon may affect the levels of male or female hormones (testosterone or prolactin). This may affect menstrual periods in women, sexual desire in men, or fertility (ability to have children) in either a man or a woman.

How should I take ramelteon?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medication with a full glass of water.

Take ramelteon 30 minutes before your normal bedtime. After you take ramelteon, avoid doing anything other than getting ready for bed.

Do not crush, chew, or break the tablet. Swallow it whole.

Avoid taking ramelteon together with or just after eating a high-fat meal. This will make it harder for your body to absorb the medication.

Talk with your doctor if your insomnia does not improve after 7 days of using ramelteon. You may need to be checked for other medical illnesses that may cause insomnia.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

See also: Rozerem dosage (in more detail)

What happens if I miss a dose?

Since ramelteon is usually taken as needed, you may not be on a dosing schedule. Ramelteon should be taken only within 30 minutes of your normal bedtime. Do not take extra medicine to make up a missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking ramelteon?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of ramelteon.

Ramelteon side effects

Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking ramelteon and talk with your doctor about another treatment for your sleep disorder. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking ramelteon and call your doctor at once if you have a serious side effect such as:

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  unusual thoughts or behavior, hallucinations, worsening depression, thoughts about hurting yourself;

  
  


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  a missed menstrual period;

  
  


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  nipple discharge; or

  
  


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  loss of interest in sex.

  
  

Less serious side effects may include:

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  drowsiness, tired feeling;

  
  


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  dizziness;

  
  


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  nausea; or

  
  


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  worsening sleep problems.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ramelteon?

Tell your doctor about all other medicines you use, especially:

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  donepezil (Aricept);

  
  


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  doxepin (Sinequan, Silenor);

  
  


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  methoxsalen (Oxsoralen);

  
  


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  primaquine or thiabendazole (Mintezol);

  
  


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  rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  
  


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  an antibiotic such as ciprofloxacin (Cipro), norfloxacin (Noroxin), or ofloxacin (Floxin);

  
  


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  heart rhythm medication such as amiodarone (Cordarone, Pacerone) or mexiletine (Mexitil); or

  
  


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  an antifungal medication such as fluconazole (Diflucan) or ketoconazole (Nizoral).

  
  

This list is not complete and other drugs may interact with ramelteon. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Rozerem resources

• Rozerem Side Effects (in more detail)
• Rozerem Dosage
• Rozerem Use in Pregnancy & Breastfeeding
• Drug Images
• Rozerem Drug Interactions
• Rozerem Support Group
• 27 Reviews for Rozerem - Add your own review/rating

• Rozerem Prescribing Information (FDA)


• Rozerem Monograph (AHFS DI)


• Rozerem Advanced Consumer (Micromedex) - Includes Dosage Information


• Rozerem Consumer Overview


• Rozerem MedFacts Consumer Leaflet (Wolters Kluwer)


• Ramelteon Professional Patient Advice (Wolters Kluwer)

Compare Rozerem with other medications

• Insomnia

Where can I get more information?

• Your pharmacist can provide more information about ramelteon.

See also: Rozerem side effects (in more detail)