Rozerem Warnings and Precautions

Be sure to go over all Rozerem warnings and precautions with your healthcare provider or pharmacist before starting the medication to help ensure a safe treatment process. Rozerem is not suitable for everyone and should not be taken by people who are allergic to any components used in making the medicine. Also, there are a number of potential side effects that may occur with the use of Rozerem, including changes in behavior, drowsiness, or changes in hormone levels.

Rozerem: What Should I Tell My Healthcare Provider?

Prior to taking Rozerem® (ramelteon), you should talk with your healthcare provider 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 Rozerem Warnings and Precautions

Some Rozerem precautions and warnings include:
  • Rozerem 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.


  • Rozerem can interact with certain medications (see Rozerem Interactions).
  • If you drink alcohol, let your healthcare provider know prior to starting Rozerem. In general, people should not use alcohol when taking Rozerem because it can increase the risks of developing Rozerem side effects.
  • Rozerem is considered a pregnancy Category C medicine. This means that the drug may not be safe to use during pregnancy. Talk to your healthcare provider before talking Rozerem if you are pregnant (see Rozerem and Pregnancy).
  • It is not known if Rozerem passes through breast milk. Therefore, if you are breastfeeding or plan to start breastfeeding, be sure to talk with your healthcare provider about this.
  • Rozerem is considered a sedative-hypnotic type of medication. If you notice any changes in your behavior (such as anything unusual or disturbing) while taking Rozerem or other sleep medicines, notify your healthcare provider immediately.
  • Rozerem is taken 30 minutes before bedtime. After you have taken a dose of Rozerem, do not do anything that requires complete alertness, such as driving, operating machinery, or piloting an airplane.


  • Sedative-hypnotic medications (such as Rozerem) can cause life-threatening allergic reactions. An allergic reaction to Rozerem 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.
  • Rozerem has not been studied in people with severe sleep apnea or severe chronic obstructive pulmonary disease (COPD). Rozerem is not recommended for people with serious cases of these conditions.
  • Rozerem can affect certain hormone levels, including testosterone and prolactin (see Rozerem and Prolactin Levels). Because of this, Rozerem is not recommended for use in children.
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