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Overview: Ramelteon is used to help you fall asleep. Dizziness and tiredness are common side effects. Ramelteon can affect your alertness or coordination, even the day after you take it. Do not drive or do other activities that require alertness or coordination until you know how ramelteon affects you and you feel fully awake. Tell your health care provider if your problems with sleep get worse after taking this medicine. 

Uses

What is ramelteon used for?

Ramelteon is commonly used to treat people who have trouble falling asleep, which is a condition called insomnia. 

Ramelteon may also be used for other conditions as determined by your health care provider.

How does ramelteon work (mechanism of action)?

Melatonin is a naturally occurring substance in the body that helps with sleep. Ramelteon is a medicine that mimics the effect of melatonin to help you fall asleep. 

How is ramelteon supplied (dosage forms)?

Brand and other names

  • Rozerem

Dosage forms and strengths

  • 8 mg oral tablets

How should I store ramelteon?

Ramelteon should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store it in a cool, dry place, in a tightly closed container to protect it from moisture and humidity.

Side Effects

What are the most common side effects of ramelteon?

The most common side effects of ramelteon are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Drowsiness
  • Dizziness
  • Nausea
  • Worsened sleep problems

There may be other side effects of ramelteon that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of ramelteon?

While less common, the most serious side effects of ramelteon are described below, along with what to do if they happen.

Severe Allergic Reactions. Ramelteon may cause allergic reactions, which can be serious or cause death. Stop taking Ramelteon and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat (angioedema)
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Changes in Mood, Thoughts, or Behavior. Depression and suicidal thoughts and actions have been reported. Some people have had hallucinations or unexpected behaviors or moods. It can also cause people to have complex sleep behaviors, which are activities that are done while not fully awake. Some examples of complex sleep behaviors are sleepwalking, sleep driving, preparing and eating food, making phone calls, and having sex. These things can be dangerous. Stop taking ramelteon and contact your health care provider right away if you have changes in your mood, thoughts, or behavior like those described here. 

Decreased Alertness or Coordination. Ramelteon can affect your alertness or coordination, even the next day. Do not drive or do other activities that require alertness or coordination until you know how ramelteon affects you and you are fully awake.

Hormone Changes. Ramelteon can change certain hormone levels in your body. It is unknown how this will affect you. Talk to your health care provider if you have any of the following symptoms that might be related to hormone changes. 

  • Changes to your monthly cycle or you stop having periods
  • Leaking milk from your breasts when you are not breastfeeding
  • Decreased sex drive
  • Trouble becoming pregnant

Warnings & Precautions

Who should not use ramelteon?

Allergies to Ingredients. People who are allergic to any of the following should not take ramelteon.

  • Rozerem
  • Ramelteon
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific ramelteon products they stock.

Drug Interactions. Ramelteon should not be taken while you are using certain other medicines. Before taking ramelteon, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

What should I know about ramelteon before using it?

Do not take ramelteon unless it has been prescribed to you by a health care provider. Take it as prescribed when you are able to get a full night’s sleep. 

Take ramelteon about 30 minutes before you would like to fall asleep. Avoid any activities after taking it other than getting ready for bed, due to the risk of changes in your mood, thoughts, or behaviors. See the Side Effects section for more details. 

Swallow ramelteon tablets whole. Do not break, chew, or crush them.

Do not share ramelteon with other people, even if they have the same condition as you. It may harm them.

If ramelteon is not helping you fall asleep within about a week or if your sleeping problems get worse, contact your health care provider. There may be another reason you are having trouble sleeping.

Keep ramelteon out of the reach of children.

What should I tell my health care provider before using ramelteon?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if ramelteon is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Liver problems
  • Depression, thoughts of suicide (or actions), or other mental health problems
  • Breathing problems, such as obstructive sleep apnea or chronic obstructive pulmonary disease (COPD)

Pregnancy. It is not known if or how ramelteon could affect pregnancy or harm an unborn baby. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should take ramelteon while you are pregnant or trying to get pregnant.

Breastfeeding. It is not known if ramelteon passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take ramelteon while breastfeeding. If you take ramelteon while you are breastfeeding, monitor your baby for excessive sleepiness and feeding problems. If you notice either of these, contact your health care provider. 

Interactions

Does ramelteon interact with foods or drinks?

Do not take ramelteon with or right after you eat, especially a high-fat meal. Doing this could increase the amount of ramelteon in your blood and possibly increase side effects.

Do not drink alcohol while you are taking ramelteon. The risk of sleepiness or other side effects, including complex sleep behaviors, may be increased if you drink alcohol while taking ramelteon.

Does ramelteon interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking ramelteon.

  • Fluvoxamine (Luvox), which is a medicine commonly used for obsessive-compulsive disorder (OCD)
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Ketoconazole or fluconazole (Diflucan), which is a medicine used for fungal infections
  • Donepezil (Adlarity, Aricept), which is a medicine commonly used for Alzheimer’s disease
  • Doxepin, which is a medicine used for depression and anxiety
  • Any other medicine that causes dizziness and sleepiness, such as prescription pain medicines, sleep medicines, and medicines for anxiety

Many other medicines may alter the blood levels of ramelteon. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with ramelteon. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much ramelteon?

If you or someone else has used too much ramelteon, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of ramelteon?

If you miss a dose of ramelteon, do not take the missed dose later that night unless you have enough time to sleep a full night before getting out of bed. Do not take the missed dose the following day. Do not take double or extra doses.