Rozerem Rozerem is the first and only prescription sleep medication that has shown no evidence of abuse and dependence and, as a result, has not been designated as a controlled substance by the DEA. With the exception of Rozerem, all other prescription medications indicated for insomnia are classified as Schedule IV controlled substances by the DEA. Additionally, Rozerem is the first prescription insomnia medication with a new therapeutic mechanism of action in 35 years.

Patient Information Sheet

What Is 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.

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

What Are The Risks?

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

What Should I Tell My Healthcare Professional Before Taking Rozerem?

Before you start taking Rozerem, tell your healthcare professional if you: 

• have or had liver disease

• have breathing problems when you sleep (severe sleep apnea) or a lung disease called severe chronic obstructive pulmonary disease (COPD).  Rozerem is not recommended if you have these problems.

• are trying to become pregnant, already pregnant, or are breastfeeding

• a history of depression, mental illness, or suicidal thoughts; or

• a history of drug or alcohol addiction.

If you have any of these conditions, you may not be able to use Rozerem, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not know whether Rozerem passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Rozerem 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 men or women.

The sedative effects of Rozerem may be stronger in older adults. Accidental falls are common in elderly patients who take sedatives. Use caution to avoid falling or accidental injury while you are taking Rozerem.

Rozerem may be habit-forming and should be used only by the person it was prescribed for. Rozerem should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Can Other Medicines or Food Affect 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)

Tell your healthcare provider if you drink alcohol.  Alcohol may increase the side effects with Rozerem.

How Should I Take Rozerem?

• Take Rozerem by mouth within 30 minutes of going to bed.

• Do not take Rozerem with or right after a high fat meal.

Rozerem Approved 2005