What is Rozerem, and how does it work (mechanism of action)?
Ramelteon is an oral drug that promotes
falling asleep and is used for treating insomnia. It acts by stimulating
receptors for melatonin in the brain. Melatonin and its receptors control the
circadian rhythm of the body which controls the sleep/wake cycle. Unlike many
drugs used for treating insomnia, ramelteon is not addictive, and it is not a
controlled substance. Ramelteon also does not cause withdrawal symptoms or
rebound insomnia when it is stopped. Ramelteon was approved by the FDA in July
1995.
What brand names are available for Rozerem?
Rozerem
Is Rozerem available as a generic drug?
No.
Do I need a prescription for Rozerem?
Yes.
What are the side effects of Rozerem?
Side effects associated with ramelteon include:
Rare cases of severe allergic reactions involving swelling of the tongue and
closure of the throat have been reported.
Other important side effects include:
- Abnormal thinking,
- behavior changes,
- depression,
- suicidal thoughts,
- manic episodes, and
- sleep driving.
What is the dosage for Rozerem?
The recommended dose of ramelteon is 8 mg taken 30 minutes
before bedtime. Ramelteon should not be taken with or immediately after a high
fat meal because fat increases its absorption from the intestine.
Which drugs or supplements interact with Rozerem?
Doxepin
(Sinequan, Adapin), donepezil (Aricept),
fluvoxamine (Luvox, Luvox CR),
ketoconazole
(Nizoral, Extina, Xolegel, Kuric), and fluconazole (Sporanox) increase blood levels of ramelteon,
possibly increasing side effects of ramelteon. Rifampin may decrease blood
levels of ramelteon, possibly reducing the effect of ramelteon. Alcohol
increases the sedative effects ramelteon.
Is Rozerem safe to take if I’m pregnant or breastfeeding?
Ramelteon has not been evaluated in
pregnant women. Animal
studies show that it may cause harm. Therefore, ramelteon should not be used in
pregnant women unless it is absolutely necessary.
Ramelteon has not been evaluated in
nursing mothers.
What else should I know about Rozerem?
What preparations of Rozerem are available?
How should I keep Rozerem stored?
Ramelteon should be store at room temperature, between 15 C – 30 C (59 F – 86 F).