Rozerem Patient Information

Brand Names: Rozerem
Generic Name: ramelteon

Rozerem (ramelteon) full prescribing information

What is Rozerem?

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 other purposes not listed in this medication guide.

Important information about Rozerem

Do 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 this medicine 30 minutes before your normal bedtime. After you take Rozerem, 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 Rozerem and talk with your doctor about another treatment for your sleep disorder.

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

Do not use Rozerem if you are allergic to ramelteon, or if you have severe liver disease.

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

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use Rozerem:

• liver disease
• sleep apnea (breathing stops while you are asleep)
• a breathing disorder such as chronic obstructive pulmonary disease (COPD)
• a history of depression, mental illness, or suicidal thoughts.

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

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 it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. 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.

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 Rozerem at room temperature away from moisture and heat.

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 if you think you have used too much of this medicine. Symptoms of a Rozerem overdose are not known.

What should I avoid while taking Rozerem?

Rozerem can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol while you are taking this medicine. Alcohol may add to sleepiness caused by ramelteon.

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: 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:

• unusual thoughts or behavior, hallucinations, worsening depression, thoughts about hurting yourself
• a missed menstrual period
• nipple discharge
• loss of interest in sex.

Less serious Rozerem side effects may include:

• drowsiness
• dizziness
• headache
• nausea.

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 Rozerem?

Before taking Rozerem, tell your doctor if you are taking any of the following drugs:

• methoxsalen (Oxsoralen)
• primaquine o thabendazole (Mintezol)
• rifampin (Rifadin, Rifater, Rifamate, Rimactane)
• an antibiotic such as ciprofloxacin (Cipro), norfloxacin (Noroxin), or ofloxacin (Floxin)
• heart rhythm medication such as amiodarone (Cordarone, Pacerone) or mexiletine (Mexitil)
• an antifungal medication such as fluconazole (Diflucan) or ketoconazole (Nizoral)

This list is not complete and there may be other drugs that can interact with Rozerem. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about Rozerem.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

last updated: 10/2009

Rozerem (ramelteon) full prescribing information

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