Drug Database - Rozerem

Generic Name: ramelteon (ram-L-tee-on)

Brand Names: Rozerem®

Classification: Sleep Medication

Issue Date: 2005

Rozerem is in a class of drugs called sleep medications. Rozerem affects chemicals in your brain that may affect sleep. Rozerem induces sleep and causes relaxation. It is used to treat insomnia.

Use caution when driving, operating machinery, or performing other hazardous activities. Rozerem will cause drowsiness and may cause dizziness. If you experience drowsiness or dizziness, avoid these activities. Rozerem should be taken just before bedtime. You may experience some carryover effects the next day.

Take Rozerem within 30 minutes prior to going to bed and limit your activities to those necessary to prepare for bed. Do not take Rozerem with or immediately after a high fat meal.

Talk to your health care provider if you experience a worsening of insomnia or any new mental or physical problems that concern you. Contact your health care provider if you experience any of the following:

• decreased sex drive
• excessive flow of milk from the breasts during nursing
• milk flow from the breasts that is not associated with nursing of an infant in women
• a loss of menses (period) in women
• fertility problems

Take Rozerem exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Take Rozerem within 30 minutes prior to going to bed and limit your activities to those necessary to prepare for bed.

You can take Rozerem with or without food but for Rozerem to work best, do not take it with or immediately after a high-fat, heavy meal.

Do not crush or chew the tablets. Take each tablet whole. Take Rozerem only if you are able to get a full night's sleep (8 or more hours) before you must be active again. Do not take more of this medication than is prescribed for you. Store Rozerem at room temperature away from moisture and heat.

Before taking this medication, tell your doctor if you have:

• liver disease
• sleep apnea
• take fluvoxamine (Fluvox)
• are depressed or have suicidal thoughts

You may not be able to take Rozerem, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

It is unknown whether Rozerem will harm an unborn baby. Do not take Rozerem without first talking to your doctor if you are pregnant. It is unknown if Rozerem passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

If you are over 65 years of age, you may be more likely to experience side effects from Rozerem. You may require a lower dose of this medication.

Since Rozerem is usually taken only if you need it to help you sleep, missing a dose will not cause any problems.

Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction:

• skin rash or hives
• difficulty breathing
• swelling of your face, lips, tongue, or throat

Contact your doctor if you experience:

• decreased sex drive
• excessive flow of milk from the breasts during nursing
• milk flow from the breasts not associated with nursing of an infant in women
• a loss of menses (period) in women
• fertility problems
• daytime drowsiness, dizziness, or clumsiness
• more outgoing or aggressive behavior than normal
• confusion
• strange behavior
• memory loss problems
• agitation
• hallucinations
• new feelings of depression

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Before taking Rozerem, tell your doctor if you are taking:

• fluvoxamine (Fluvox®)
• rifampin (Rifadin®)
• ketoconazole (Nizoral®)
• fluconazole (Diflucan®)

You may not be able to take Rozerem, or you may require a dosage adjustment or special monitoring during treatment.

Drugs other than those listed here may also interact with Rozerem or affect your condition. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.