Ramelteon

Ramelteon is a prescription medication used to treat insomnia. Ramelteon belongs to a group of drugs called melatonin receptor agonists, which act like melatonin to promote sleep.

This medication comes in tablet form. It is usually taken once a day, within 30 minutes of going to bed, with a full glass of water. Do not break the tablets. Swallow tablets whole.

Do not take ramelteon with or right after a meal. This may delay how fast ramelteon will work or reduce how ramelteon works.

Common side effects of ramelteon are drowsiness, tiredness, and dizziness.

Ramelteon is a prescription sleep medicine. It is for adults that have insomnia, particularly difficulty falling asleep. Unlike many sleep medications, ramelteon is not habit-forming. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Ramelteon may be found in some form under the following brand names:

• Rozerem

Possible serious side effects of ramelteon include:

• severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking ramelteon.
• getting out of bed while not being fully awake and do an activity that you do not know you are doing. See "Precautions".
• abnormal thoughts and behavior. Symptoms include worsening of depression, suicidal thoughts or actions, nightmares, and hallucinations.
• hormone effects. Ramelteon can decrease testosterone levels and increase prolactin levels in the blood. Symptoms of low testosterone or high prolactin levels are:
  • decreased interest in sex
  • problems getting pregnant
  • irregular menstrual periods or no menstrual periods
  • leakage of milk from the nipples of a person who is not breastfeeding

The most common side effects of ramelteon are:

• drowsiness
• tiredness
• dizziness
• 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.

This is not a complete list of ramelteon side effects. Talk to your doctor if you have questions or concerns about side effects.

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects.

Do not take ramelteon with:

• Other medicines that can make you sleepy
• Luvox (fluvoxamine)

This is not a complete list of ramelteon drug interactions. Ask your doctor or pharmacist for more information.

Ramelteon may cause severe allergic reactions. Symptoms include:

• swelling of the tongue or throat
• trouble breathing
• nausea
• vomiting

Seek emergency medical attention if you get these symptoms after taking ramelteon. Do not take ramelteon if you are allergic to any of the ingredients in ramelteon.

After taking ramelteon, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing including:

• driving a car ("sleep-driving")
• making and eating food
• talking on the phone
• having sex
• sleep-walking

The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with ramelteon. Call your doctor right away if you find out that you have done any of the above activities after taking ramelteon.

Take ramelteon about 30 minutes before going to bed. Do not take it sooner. Take ramelteon if you can get a full night's sleep. Take ramelteon exactly as prescribed. Never take more than prescribed.

Do not drink alcohol while taking ramelteon.

Do not take ramelteon with other medicines that make you sleepy.

Grapefruit and grapefruit juice may interact with ramelteon and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before starting ramelteon, tell your doctor about all of your health conditions, including if you:

• have a history of depression
• have a history of mental illness, or suicidal thoughts
• have liver disease
• have a lung disease or breathing problems

Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

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

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if ramelteon is excreted in human breast milk or if it will harm your nursing baby.

• Take ramelteon exactly as prescribed. Do not take more ramelteon than prescribed for you.
• Do not break the tablets. They should be swallowed whole.
• Take ramelteon within 30 minutes of going to bed. After taking ramelteon only do activities to get ready for bed.
• Do not take ramelteon with or right after a meal. This may delay how fast ramelteon will work or reduce how ramelteon works.
• Do not take ramelteon unless you are able to get a full night's sleep before you must be active again.
• Call your doctor if your insomnia worsens or is not better within 7-10 days. This may mean that there is another condition causing your sleep problems.
• If you take too much ramelteon or overdose, call your doctor or poison control center right away, or get emergency treatment.

Take ramelteon exactly as prescribed. Follow the directions on your prescription label carefully.

The recommended dose of ramelteon is 8 mg taken within 30 minutes of going to bed.

If you take too much ramelteon, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store ramelteon tablets at room temperature. Keep the container tightly closed and protected from moisture and humidity.
• Keep ramelteon and all medicines out of reach of children.