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ramelteon (cont.)

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

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;
  • sleep apnea (breathing stops while you are asleep);
  • a breathing disorder such as chronic obstructive pulmonary disease (COPD); or
  • 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 (Rozerem)?

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.

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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