Ramelteon is a prescription sleep medicine that is used to treat people with insomnia who have trouble falling asleep.

Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

Be sure that you are able to devote 7 to 8 hours to sleep before being active again. Never take this medicine during your normal waking hours, unless you have at least 7 to 8 hours to dedicate to sleeping.

Ramelteon should be taken within 30 minutes of bedtime. Do not take with alcohol or with other medicines that can make you sleepy. You should not drive or operate machinery at night after taking Ramelteon. Until you know how you will react to Ramelteon, you should be careful in performing such activities during the day following taking Ramelteon. Before you take Ramelteon, tell your doctor if you have a history of depression, mental illness or suicidal thoughts. You should call your doctor right away if after taking Ramelteon you walk, drive, eat or engage in other activities while asleep. Drowsiness is the most common adverse event observed in clinical trials. For more information, please see the complete Prescribing Information, including the Medication Guide.

What should I tell my healthcare provider before taking Ramelteon?

Before you take Ramelteon, tell your healthcare provider if you:

• Have a history of depression, mental illness, or suicidal thoughts
• Have severe sleep apnea
• Have kidney or liver problems
• Have a history of drug or alcohol abuse or addiction
• Have a history of glaucoma or urinary retention
• Have any other medical conditions

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.

Ramelteon and other medicines may affect each other causing side effects. Ramelteon may affect the way other medicines work, and other medicines may affects how Ramelteon works. Especially tell your healthcare provider if you take: Luvox (fluvoxamine).

Who should not take Ramelteon?

You should not use Ramelteon if you are allergic to it, or if:

• You have severe liver disease; or
• You also take fluvoxamine.

Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

Do not use Ramelteon for a condition for which it was not prescribed. Do not share Ramelteon with other people, even if you think they have the same symptoms that you have. It may harm them.

INDICATIONS

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.

Dosing In Adults

The recommended dose of Ramelteon is 8 mg taken within 30 minutes of going to bed. It is recommended that Ramelteon not be taken with or immediately after a high-fat meal. The total Ramelteon dose should not exceed 8 mg per day.

Dosing In The Elderly

The recommended starting dose of Ramelteon in elderly patients (≥ 65 years old) is 8 mg once daily.

Administration

Ramelteon should be taken within 30 minutes of bedtime.

To minimize the potential for next day effects, Ramelteon should not be taken within 3 hours of a meal.

The total Ramelteon dose should not exceed 8 mg per day.

How should I take Ramelteon?

• Take Ramelteon exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much Ramelteon to take and when to take them.
• Your healthcare provider may change your dose if needed.
• Take Ramelteon within 30 minutes of bedtime. After taking Ramelteon, you should confine your activities to those necessary to prepare for bed.
• Do not take Ramelteon within 3 hours of a meal. Ramelteon may not work as well, or may make you sleepy the next day if taken with or right after a meal.
• Do not take Ramelteon unless you are able to get a full night of sleep before you must be active again.

Call your healthcare provider if your sleep problems get worse or do not get better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

If you take too much Ramelteon, call your doctor or get medical help right away.

What should I avoid while taking Ramelteon?

You should not drink alcohol while taking Ramelteon. Alcohol can increase your chances of getting serious side effects with Ramelteon. You should not drive, operate heavy machinery, or do other dangerous activities after Ramelteon. You may still feel drowsy the next day after taking Ramelteon. Do not drive or do other dangerous activities after taking Ramelteon until you feel fully awake.

What is the most important information I should know about Ramelteon?

The most common side effect of Ramelteon is drowsiness or tiredness.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Ramelteon. For more information ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store Ramelteon?

Store Ramelteon between 68° and 77°F (20° to 25°C).

Keep Ramelteon in a tightly closed container, and away from light. Safely throw away medicine that is out of date or no longer needed.

Keep Ramelteon and all medicines out of the reach of children.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.