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Rozerem Patient Information Including Side Effects

Brand Names: Rozerem

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

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 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)?

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, 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.

Read the Rozerem (ramelteon) Side Effects Center for a complete guide to possible side effects

What is the most important information I should know about 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).

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.

Side Effects Centers

Rozerem - User Reviews

Rozerem User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Rozerem sorted by most helpful. Patient Discussions FAQs

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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