Rozerem

Rozerem is a prescription medication used to treat insomnia. Rozerem 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 Rozerem with or right after a meal. This may delay how fast Rozerem will work or reduce how Rozerem works.

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

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

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

• Takeda Pharmaceuticals America, Inc.

Possible serious side effects of Rozerem 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 Rozerem.
• 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. Rozerem 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 Rozerem are:

• drowsiness
• tiredness
• dizziness
• You may still feel drowsy the next day after taking Rozerem. Do not drive or do other dangerous activities after taking Rozerem until you feel fully awake.

This is not a complete list of Rozerem 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 Rozerem with:

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

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

Rozerem 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 Rozerem. Do not take Rozerem if you are allergic to any of the ingredients in Rozerem.

After taking Rozerem, 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 Rozerem. Call your doctor right away if you find out that you have done any of the above activities after taking Rozerem.

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

Do not drink alcohol while taking Rozerem.

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

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

Before starting Rozerem, 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 Rozerem is excreted in human breast milk or if it will harm your nursing baby.

• Take Rozerem exactly as prescribed. Do not take more Rozerem than prescribed for you.
• Do not break the tablets. They should be swallowed whole.
• Take Rozerem within 30 minutes of going to bed. After taking Rozerem only do activities to get ready for bed.
• Do not take Rozerem with or right after a meal. This may delay how fast Rozerem will work or reduce how Rozerem works.
• Do not take Rozerem 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 Rozerem or overdose, call your doctor or poison control center right away, or get emergency treatment.

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

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

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

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