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.

Ramelteon may also be used for purposes not listed in this medication guide.

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

Ramelteon 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.

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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take ramelteon 30 minutes before your normal bedtime.

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

Ramelteon 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 ramelteon.

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

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

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

• you have severe liver disease; or

• you also take fluvoxamine.

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 ramelteon. 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.

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

Since ramelteon 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Do not drink alcohol with ramelteon.

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

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

Some people using ramelteon 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.

Ramelteon may cause serious side effects. 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 side effects of ramelteon 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 ramelteon 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 affect 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.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.