 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.
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