How Food Can Affect Rozerem (Ramelteon)

Answer

Thank you for your great question.

According to the FDA prescribing information for Ramelteon, it is recommended to not take the medication with or immediately after a high-fat meal. Doing so may reduce the medication's effectiveness.

Specifically, the prescribing information for the drug (label (fda.gov)) states the following:

Effect of Food: When administered with a high-fat meal, the AUC_0-inf for a single 16 mg dose of ROZEREM was 31% higher, and the C_max was 22% lower than when given in a fasted state. The median T_max was delayed by approximately 45 minutes when ROZEREM was administered with food. The effects of food on the AUC values for M-II were similar. It is therefore recommended that ROZEREM not be taken with or immediately after a high-fat meal [see Dosage and Administration (2.1)].

To help explain the above excerpt:

• AUC (Area Under the Curve) measures the total exposure of the body to the medication over time, while Cmax represents the maximum concentration of the drug in the blood after taking a dose.
• A higher AUC indicates that the body is exposed to the drug for a longer period, while a lower Cmax suggests that the peak concentration of the drug is reduced.
• Both of these factors can affect how quickly and effectively the medication works.

In practical terms, for someone taking Rozerem, this means that taking the medication with a high-fat meal could lead to a longer duration of drug exposure but with a lower peak concentration. The main concern with taking it with or immediately after a high-fat meal is that it would slow absorption, which may reduce its effect on sleep latency (i.e., you may not fall asleep as quickly).

I can't speak to why the instructions on your bottle state to take it with a high-fat meal.

It's possible those instructions came from your healthcare provider and were, therefore, included on the pharmacy bottle. There may be a specific reason your provider wants you to take it that way, but I can't be certain.

All I can say for sure is that, in general, the drug is not recommended to be taken with a high-fat meal. You should consult your doctor or pharmacist about it for more personalized advice and better insight as to why your prescription directions are the way they are.

Final Words

I hope this was helpful!

Thanks again for reaching out.