Ramelteon, Oral

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KEY POINTS

• This medicine is taken by mouth to treat the kind of insomnia in which people have trouble falling asleep. Take it exactly as directed.
• This medicine may cause walking or driving in your sleep, amnesia, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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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.

This medicine may be used to treat other conditions as determined by your healthcare provider.

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 or thoughts of suicide
• Liver problems
• Lung or breathing problems such as asthma, COPD, or sleep apnea

Do not take fluvoxamine (Luvox CR) 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?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

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.

Check with your healthcare provider before using this medicine in children under age 18.

Take this medicine on an empty stomach. Do not take this medicine with or right after a high-fat or large meal. Swallow the tablet whole. Do not break, crush, or chew the tablets.

This medicine acts quickly, usually in about 30 minutes. Take this medicine within 30 minutes of 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.

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
• Depression or 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 10 days or if it gets worse.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

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 these to your healthcare provider right away.): Hallucinations (seeing or hearing things that are not there); depression; suicidal thoughts; severe confusion or memory problems; constant drowsiness; irregular menstrual periods or no menstrual periods; nipple discharge.

Other: Minor sleepiness or dizziness the morning after a dose of this medicine, nausea, headache, change in sexual ability or 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:

• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antibiotics such as azithromycin (Zithromax, Zmax), ciprofloxacin (Cipro), erythromycin (E.E.S., Ery-Tab, Erythrocin), ofloxacin, rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), clomipramine, desipramine (Norpramin), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, and venlafaxine (Effexor)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), and hydroxyzine (Vistaril)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), perphenazine, pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), ezogabine (Potiga), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), phenytoin (Dilantin, Phenytek), primidone (Mysoline), tiagabine (Gabitril), and topiramate (Qudexy, Topamax, Trokendi)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cancer medicines such as abiraterone (Zytiga) and vemurafenib (Zelboraf)
• Cimetidine (Tagamet)
• Donepezil (Aricept)
• Doxepin (Silenor)
• Gemfibrozil (Lopid)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Methoxsalen (8-MOP, Oxsoralen Ultra, Uvadex)
• Mexiletine
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• Narcotic pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), and pentazocine (Talwin)
• Natural remedies such as gotu kola, kava, St. John's wort, and valerian
• Nausea medicines such as prochlorperazine (Compro) and promethazine
• Other sleeping pills such as zaleplon (Sonata) and zolpidem (Ambien, Edluar, Intermezzo)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Primaquine

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

Do not drink alcohol while you are taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. 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.

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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.