Patient Information Sheet
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.
Should Not Take Rozerem?
You should not take
Rozerem if you have any of the following conditions:
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:
Should I Tell My Healthcare Professional Before Taking Rozerem?
you start taking Rozerem, tell your healthcare professional
have or had liver
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.
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
Especially, tell your healthcare
professional if you take:
- rifampin (Rifadin)
- ketoconazole (Nizoral)
- fluconazole (Diflucan)
Tell your healthcare
provider if you drink alcohol. Alcohol may increase the side
effects with Rozerem.
Should I Take Rozerem?
Rozerem Approved 2005