 The
following information is a summary about Rozerem. It is
not intended to replace a doctor's instructions.
What Is Rozerem?
Rozerem is a prescription medicine for adults to treat
insomnia where the problem is trouble falling asleep.
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.
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.
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 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.
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. |
