Brand Names: Rozerem

Generic Name: ramelteon (Pronunciation: ram EL tee on)

• What is ramelteon (Rozerem)?
• What are the possible side effects of ramelteon (Rozerem)?
• What is the most important information I should know about ramelteon (Rozerem)?
• What should I discuss with my healthcare provider before taking ramelteon (Rozerem)?
• How should I take ramelteon (Rozerem)?
• What happens if I miss a dose (Rozerem)?
• What happens if I overdose (Rozerem)?
• What should I avoid while taking ramelteon (Rozerem)?
• What other drugs will affect ramelteon (Rozerem)?
• Where can I get more information?

What is ramelteon (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."

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 other purposes not listed in this medication guide.

Rozerem 8 mg

round, yellow, imprinted with TAK RAM-8

What are the possible side effects of ramelteon (Rozerem)?

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:

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

Less serious side effects may include:

• drowsiness;
• dizziness;
• headache; or
• 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 is the most important information I should know about ramelteon (Rozerem)?

Do 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.