Rozerem (ramelteon) is a sedative, also called a hypnotic. It works by affecting certain substances in your body that help regulate your "sleep-wake cycle."
Rozerem 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.
Rozerem may also be used for purposes not listed in this medication guide.
Important information
You should not use Rozerem if you are allergic to ramelteon, or if you have severe liver disease.
You should not take Rozerem if you are also taking the antidepressant fluvoxamine (Luvox).
Before taking Rozerem, 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 Rozerem 30 minutes before your normal bedtime. After you take this medicine, avoid doing anything other than getting ready for bed.
Avoid taking Rozerem 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 Rozerem and talk with your doctor about another treatment for your sleep disorder.
Before taking this medicine
You should not use Rozerem if you are allergic to ramelteon, or if you have severe liver disease.
You should not take Rozerem if you are also taking the antidepressant fluvoxamine (Luvox).
To make sure you can safely take Rozerem, 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 Rozerem 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.
See also: Pregnancy and breastfeeding warnings (in more detail)
Rozerem 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 Rozerem?
Take Rozerem 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 Rozerem 30 minutes before your normal bedtime. After you take Rozerem, avoid doing anything other than getting ready for bed.
Do not crush, chew, or break the tablet. Swallow it whole.
Avoid taking Rozerem 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 Rozerem. You may need to be checked for other medical illnesses that may cause insomnia.
Store this medicine at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.
What happens if I miss a dose?
Since Rozerem is usually taken as needed, you may not be on a dosing schedule. Rozerem 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?
Rozerem 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 Rozerem.
Rozerem 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 Rozerem 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 to Rozerem: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking Rozerem 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 Rozerem side effects may include:
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.
See also: Side effects (in more detail)
What other drugs will affect Rozerem?
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 Rozerem. 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.
