Rozerem 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, Rozerem is not known to be habit-forming.

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.

You should not use Rozerem if you are also taking fluvoxamine (Luvox), or if you have ever had a severe allergic reaction to ramelteon.

Rozerem may cause a severe allergic reaction. Get emergency medical help if you have hives; difficult breathing; nausea and vomiting; swelling of your face, lips, tongue, or throat.

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

Avoid taking this medicine 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 while not fully awake and later had no memory of it. If this happens to you, call your doctor right away.

Before taking this medicine

Rozerem will make you fall asleep. Never take this medicine during your normal waking hours, unless you have at least 7 to 8 hours to dedicate to sleeping.

You should not use Rozerem if you are allergic to ramelteon, or if:

• you have severe liver disease; or

• you also take fluvoxamine.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• liver disease;

• breathing problems;

• sleep apnea (breathing stops while you are asleep); or

• depression, mental illness, or suicidal thoughts.

Tell your doctor if you are pregnant or breastfeeding.

You should not breastfeed within 25 hours after using Rozerem. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your 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.

Rozerem is not approved for use by anyone younger than 18 years old.

Take Rozerem exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take Rozerem 30 minutes before your normal bedtime.

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

Rozerem should not be taken with or after a high-fat meal. This will make it harder for your body to absorb the medication.

Call your doctor if your symptoms do not improve after 7 to 10 days of using this medicine.

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

Usual Adult Dose for Insomnia:

8 mg orally within 30 minutes of going to bed

Maximum Dose: 8 mg per day

Comments: This drug should not be taken with or immediately after a high-fat meal.

Use: Treatment of insomnia characterized by difficulty with sleep onset

Rozerem will make you fall asleep. Never take this medicine during your normal waking hours, unless you have at least 7 to 8 hours to dedicate to sleeping.

You should not use Rozerem if you are allergic to ramelteon, or if:

• you have severe liver disease; or

• you also take fluvoxamine.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• liver disease;

• breathing problems;

• sleep apnea (breathing stops while you are asleep); or

• depression, mental illness, or suicidal thoughts.

Tell your doctor if you are pregnant or breastfeeding.

You should not breastfeed within 25 hours after using Rozerem. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your 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.

Rozerem is not approved for use by anyone younger than 18 years old.

Since Rozerem is taken only at bedtime if needed, you are not likely to miss a dose. Never take this medication if you do not have 7 to 8 hours to sleep before being active again.

Do not take two doses at one time.

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

Do not drink alcohol with this medicine.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Rozerem may cause a severe allergic reaction. Get emergency medical help if you have signs of an allergic reaction to Rozerem: hives; difficult breathing; nausea and vomiting; swelling of your face, lips, tongue, or throat.

Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. This may include walking, driving, eating, having sex, or making phone calls. If this happens to you, call your doctor right away.

Call your doctor at once if you have:

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

• a missed menstrual period;

• nipple discharge; or

• loss of interest in sex.

Common Rozerem side effects may include:

• drowsiness, tired feeling;

• dizziness;

• nausea; or

• 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.

Using Rozerem with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may interact with ramelteon, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.