The below information on Rozerem has been taken from official FDA sources, but we cannot guarantee it's accuracy. Please use this site for educational purposes only. This site does not replace a proper discussion with your doctor.

    Brand Name:Rozerem
This drug was approved by the FDA in one form or another on:
2005-07-22 ,
This drug is made in one form or another by the following companies:
Takeda Global Research & Development Center, Inc.
This drug is available in the following forms:
View the actual FDA approved label for this drug at the following links:

About Rozerem

Rozerem is a prescription medicine for adults to treat insomnia where the problem is trouble falling asleep.

Rozerem has not been studied in children. It is not known if Rozerem is safe and effective for children.

Side Effects of Rozerem

The following are the major potential risks and side effects of Rozerem therapy. However, this list is not complete. The following are the major potential risks and side effects of Rozerem therapy:

  • Worsening of insomnia, mental, or behavior changes. These may happen if your insomnia is caused by a mental or medical problem. Your healthcare professional should check you carefully for other health problems before prescribing Rozerem. Tell your healthcare professional if you develop:
  • worse insomnia
  • mental problems including thoughts of harming yourself
  • behavior changes
  • Drowsiness. Rozerem may affect your ability to drive or do other dangerous activities. Do not do these activities after taking Rozerem. After taking Rozerem, do only activities needed to get ready for bed.
  • Affect reproductive hormones. Rozerem may affect the reproductive hormones by increasing prolactin and potentially decreasing testosterone levels. This may cause missed monthly periods, nipple drainage, decreased sex drive, or problems getting pregnant. Your healthcare professional may do blood tests to check your hormone levels if you have any of these symptoms.
  • Some common side effects that may occur with Rozerem include:
  • headache
  • daytime sleepiness
  • dizziness
  • tiredness
  • nausea
  • worsening insomnia
  • colds

Who Should Not Take Rozerem

You should not take Rozerem if you have any of the following conditions:

  • are allergic to ramelteon or any of its ingredients
  • have severe liver disease

Interactions with Rozerem

Rozerem and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how Rozerem works or Rozerem may affect how your other medicines work. Know the medicines you take. Keep a list of them with you to show your healthcare professional.

Especially, tell your healthcare professional if you take:

  • fluvoxamine
  • rifampin (Rifadin)
  • ketoconazole (Nizoral)
  • fluconazole (Diflucan)
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Recent Forum Posts on Rozerem

No Subject

I've been taking Rozerem for a few months now due to chronic back & leg pain. It works for me and I especially like it because it isn't like "typical" sleep aides. It's basically a very strong melatonin which does not cause me to feel foggy or spaced out the next morning. I do not like other sleep medications because they can cause dependency if taken for a long time and cause me to feel spaced out, but Rozerem does not. I'm glad it is available.


I have been taking Rozerem for 9 days. I don't like this medication, it does not work at all. It takes me a while to fall asleep then I keep waking up during the night. The next day I feel really spaced-out and tired, like I've been drugged. I can't concentrate and my though process and memory is foggy. I'm going to stop taking it and stick to tamazapam which works way better and doesn't have that hangover effect. I think they should take it off the market.

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