Precautions and Warnings With Ramelteon

Before starting treatment, there are many important precautions and warnings with ramelteon to be aware of. You should let your healthcare provider know if you have existing medical conditions such as liver disease or liver failure, depression, or sleep apnea. Also, side effects may occur when taking this drug, including drowsiness, changes in behavior, and changes in certain hormone levels. Do not take the sleep medicine if you are allergic to any components of ramelteon or have severe liver problems.

Ramelteon: What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking ramelteon (Rozerem®) if you have:
Also, let your healthcare provider know if you:
  • Are pregnant or thinking about becoming pregnant
  • Are breastfeeding
  • Drink alcohol.
Also, tell your healthcare provider about all other medicines you may currently be taking, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Some Ramelteon Warnings and Precautions

Patients taking this drug should keep the following warnings and precautions in mind:
  • Ramelteon can cause very severe allergic reactions. Seek immediate medical attention if you notice any signs of an allergic reaction, such as hives, itching, a rash, difficulty breathing, or swelling of the mouth or throat.


  • Ramelteon can interact with certain medications (see Drug Interactions With Ramelteon).
  • If you drink alcohol, let your healthcare provider know prior to starting ramelteon. In general, people should not use alcohol when taking ramelteon because it can increase the risks of developing ramelteon side effects.
  • Ramelteon is considered a pregnancy Category C medicine. This means that it may not be safe to use during pregnancy. Talk to your healthcare provider before talking ramelteon if you are pregnant (see Rozerem and Pregnancy).
  • It is not known if ramelteon passes through breast milk. Therefore, if you are breastfeeding or plan to start breastfeeding, be sure to talk with your healthcare provider about this.
  • Ramelteon is considered a sedative-hypnotic type of medication. If you notice any changes in your behavior (such as anything unusual or disturbing) while taking ramelteon or other sleep medicines, notify your healthcare provider immediately.


  • Sedative-hypnotic medications (such as ramelteon) can cause life-threatening allergic reactions. An allergic reaction to ramelteon can occur even with your first dose of the drug. Be sure to tell your healthcare provider right away if you have any signs of an allergic reaction, such as an unexplained rash, itching, hives, wheezing or trouble breathing, or unexplained swelling (especially of the throat, lips, or mouth).
  • There have been reports of "sleep-driving," "sleep-eating," or other unusual behaviors in people taking sedative-hypnotic medications. In general, people do not remember doing these things when they wake up in the morning. These activities can be dangerous, since people are not fully awake or alert.


  • Ramelteon is taken 30 minutes before bedtime. After you have taken a dose of ramelteon, do not do anything that requires complete alertness, such as driving, operating machinery, or piloting an airplane.
  • Ramelteon has not been studied in people with severe sleep apnea or severe chronic obstructive pulmonary disease (COPD). Ramelteon is not recommended for people with serious cases of these conditions.
  • Ramelteon can affect certain hormone levels, including testosterone and prolactin (see Rozerem and Prolactin Levels). Because of this, ramelteon is not recommended for use in children.

Ramelteon (Rozerem)

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