ROZEREM- ramelteon tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ramelteon (UNII: 901AS54I69) (ramelteon - UNII:901AS54I69)

Available from:

Takeda Pharmaceuticals America, Inc.

INN (International Name):

ramelteon

Composition:

ramelteon 8 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ROZEREM is indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. The final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see Clinical Studies (14)] . Patients who develop angioedema after treatment with ROZEREM should not be rechallenged with the drug. Patients should not take ROZEREM in conjunction with fluvoxamine [see Drug Interactions (7)] . Risk Summary Available data from postmarketing reports with ROZEREM use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, ramelteon produced evidence of developmental toxicity, including teratogenic effects, in rats at doses greater than 36 times the rec

Product summary:

ROZEREM is available as round, pale orange-yellow, film-coated, 8 mg tablets, with "TAK" and "RAM-8" printed on one side, in the following quantities: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protected from moisture and humidity.

Authorization status:

New Drug Application

Patient Information leaflet

Takeda Pharmaceuticals America, Inc.
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MEDICATION GUIDE
ROZEREM (rō-Zair-em)
(ramelteon)
Read the Medication Guide that comes with ROZEREM before you start
taking it and each time you get a
refill. There may be new information. This Medication Guide does not
take the place of talking to your
doctor about your medical condition or treatment.
What is the most important information I should know about ROZEREM?
ROZEREM may cause severe allergic reactions. Symptoms include swelling
of the tongue or throat,
trouble breathing, and nausea and vomiting. Get emergency medical help
if you get these symptoms after
taking ROZEREM.
After taking ROZEREM, you may get up out of bed while not being fully
awake and do an activity that
you do not know you are doing. The next morning, you may not remember
that you did anything during
the night. You have a higher chance for doing these activities if you
drink alcohol or take other medicines
that make you sleepy with ROZEREM. Activities may include:
•
driving a car ("sleep-driving")
•
making and eating food
•
talking on the phone
•
having sex
•
sleep-walking
Call your doctor right away if you find out that you have done any of
the above activities after taking
ROZEREM.
Important:
1.
Take ROZEREM exactly as prescribed
•
Do not take more ROZEREM than prescribed.
•
Take ROZEREM within 30 minutes of going to bed, not sooner.
2.
Do not take ROZEREM if you:
•
drink alcohol
•
take other medicines that can make you sleepy. Talk to your doctor
about all of your
medicines. Your doctor will tell you if you can take ROZEREM with your
other medicines
•
cannot get a full night's sleep
WHAT IS ROZEREM?
ROZEREM is a hypnotic (sleep) medicine. ROZEREM is used in adults for
the treatment of the symptom
of trouble falling asleep from insomnia.
ROZEREM is not for children.
Who should not take ROZEREM?
Do not take ROZEREM if you are allergic to anything in it. See the end
of this Medication Guide for a
complete list of ingredients in ROZEREM.
Do not take ROZEREM if you are cur

Summary of Product characteristics

ROZEREM- RAMELTEON TABLET, FILM COATED
TAKEDA PHARMACEUTICALS AMERICA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ROZEREM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ROZEREM.
ROZEREM (RAMELTEON) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2005
INDICATIONS AND USAGE
ROZEREM is indicated for the treatment of insomnia characterized by
difficulty with sleep onset. (1)
DOSAGE AND ADMINISTRATION
Adult dose: 8 mg taken within 30 minutes of going to bed. (2.1)
Should not be taken with or immediately after a high-fat meal. (2.1)
Total daily dose should not exceed 8 mg. (2.1)
DOSAGE FORMS AND STRENGTHS
8 mg tablets. (3)
CONTRAINDICATIONS
History of angioedema while taking ROZEREM. (4)
Fluvoxamine (strong CYP1A2 inhibitor): Increases AUC for ramelteon and
should not be used in
combination. (7.1)
WARNINGS AND PRECAUTIONS
Severe anaphylactic/anaphylactoid reactions: Angioedema and
anaphylaxis have been reported. Do not
rechallenge if such reactions occur. (5.1)
Need to evaluate for comorbid diagnoses: Reevaluate if insomnia
persists after 7 to 10 days of
treatment. (5.2)
Abnormal thinking, behavioral changes, complex behaviors: May include
"sleep-driving" and
hallucinations. Immediately evaluate any new onset behavioral changes.
(5.3)
Depression: Worsening of depression or suicidal thinking may occur.
(5.3)
CNS effects: Potential impairment of activities requiring complete
mental alertness such as operating
machinery or driving a motor vehicle, after ingesting the drug. (5.4)
Reproductive effects: Include decreased testosterone and increased
prolactin levels. Effect on
reproductive axis in developing humans is unknown. (5.5)
Patients with severe sleep apnea: ROZEREM is not recommended for use
in this population. (5.6)
ADVERSE REACTIONS
Most common adverse reactions (≥3% and more common than with
placebo) are: somnolence, dizziness,
fatigue, nausea, and exacerbated insomnia. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TAKE