Ramelteon, Oral

What are other names for this medicine?

Type of medicine: sedative; sleeping pill; melatonin receptor agonist

Generic and brand names: ramelteon, oral; Rozerem

What is this medicine used for?

This medicine is taken by mouth to treat the kind of insomnia in which people have trouble falling asleep.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• depression
• liver problems
• lung disease such as COPD
• sleep apnea

Do not take fluvoxamine while taking this medicine.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more of this medicine or take it longer than prescribed.

Taking this medicine with or right after a high-fat or large meal may delay or reduce its effect. For faster results, take this medicine on an empty stomach. Swallow the tablet whole. Do not break, crush, or chew the tablets.

Take this medicine just before going to bed or when you will be able to sleep for at least 8 hours. Do not take more than 1 dose a night unless your healthcare provider approves.

This medicine acts quickly, usually in about 30 minutes.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

After taking this medicine, you may get up out of bed while not being fully awake and do things that you do not know you are doing, and will not remember the next morning. Examples include:

• sleep-walking
• sleep-driving
• making and eating food
• talking on the phone
• having sex

Behavior changes may be caused by the medicine or by an illness present before the medicine was used. Contact your provider right away if you or your family notice any disturbing changes in your thoughts or behavior, such as:

• more outgoing or aggressive behavior than normal
• confusion
• hallucinations
• memory problems
• worsening of depression
• suicidal thoughts

This medicine works faster than some other medicines for insomnia and may cause fewer hangover symptoms the next day. However, do not drive or operate machinery the next day unless you are fully alert.

This medicine increases the effects of alcohol and other drugs that slow down your nervous system. Do not drink alcohol while you are taking this medicine. Do not take other medicines unless your healthcare provider approves.

Contact your healthcare provider if your insomnia does not improve in about 2 weeks or if it gets worse.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report this to your healthcare provider right away): Hallucinations (seeing or hearing things that are not there), depression, suicidal thoughts, severe confusion, constant drowsiness.

Other: Minor sleepiness or dizziness the morning after a dose of this medicine, nausea, headache, fatigue, loss of sexual desire.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• alcohol
• amiodarone (Cordarone, Pacerone)
• anastrozole (Arimidex)
• antibiotics such as ciprofloxacin (Cipro), erythromycin (Ery-Tabs, E.E.S.), isoniazid (Nydrazid), and telithromycin (Ketek)
• antifungal medicines such as fluconazole (Diflucan) and ketoconazole (Nizoral)
• anti-HIV medicines such as amprenavir (Agenerase), atazanavir (Reyataz), and ritonavir (Norvir)
• fluvoxamine (Luvox) DO NOT TAKE THESE MEDICINES TOGETHER.
• natural remedies such as kava, St. John's wort, gotu kola, and valerian
• methoxsalen (Oxsoralen-Ultra, 8-MOP)
• other sleep medicines such as zolpidem (Ambien), zaleplon (Sonata), and chloral hydrate
• rifampin (Rifadin, Rimactane)
• ticlopidine (Ticlid)

Do not eat grapefruit or drink grapefruit juice while taking this medicine. Grapefruit affects the way this medicine works and may increase the risk of side effects.

Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.