RAMELTEON (Generic for ROZEREM)

Ramelteon 8mg, Oral tablet

Tobacco

· Severity: Moderate

· Notes for Consumers: Ramelteon may not work as well in treating your condition if you smoke Tobacco products. Talk to your healthcare provider if you are a smoker or change your smoking habits while taking Ramelteon. If you stop smoking tobacco you may need to watch for an increase in ramelteon side-effects, like headache, increased drowsiness, or changes in moods or behaviors. Report any unusual side effects to your health care professional.

· Notes for Professionals: Efficacy may be reduced when ramelteon is used in combination with strong CYP1A2 enzyme inducers such as tobacco smoking.

Ramelteon 8mg, Oral tablet

Grapefruit juice

· Severity: Major

· Notes for Consumers: Do not take Ramelteon with grapefruit or grapefruit juice. Taking Ramelteon with grapefruit or grapefruit juice can increase the amount of Ramelteon in the blood and can increase the risk of serious side effects. Swallow Ramelteon with some water within 30 minutes before you are ready to go to bed. Tell your health care professional if your sleep problem does not improve or gets worse.

· Notes for Professionals: Ramelteon should not taken with grapefruit or grapefruit juice. Ramelteon is a high extraction ratio drug, and grapefruit inhibits enteric CYP3A4 activity.

Ramelteon 8mg, Oral tablet

Alcohol

· Severity: Major

· Notes for Consumers: Avoid alcoholic drinks while you are taking Ramelteon. Using Ramelteon with alcohol can lead to serious side effects. Do not drive or operate machinery if you are drinking alcohol-containing beverages. If you notice slurred speech, confusion, severe weakness, or difficulty breathing, contact your health care provider immediately.

· Notes for Professionals: Because alcohol by itself impairs psychomotor performance, and the intended effect of ramelteon is to promote sleep, patients should be cautioned not to consume alcohol when using ramelteon.

Ramelteon 8mg, Oral tablet

High Fat Foods

· Severity: Major

· Notes for Consumers: Do not take Ramelteon with or immediately after a high-fate meal. Taking Ramelteon immediately after eating reduces its ability to help you sleep. Swallow Ramelteon with some water within 30 minutes before you are ready to go to bed. Tell your health care professional if your sleep problem does not improve or gets worse.

· Notes for Professionals: Patients should avoid taking ramelteon with or immediately after a meal with high fat food, as the sleep promoting effects of ramelteon may be altered. After administration with a high fat meal, the systemic exposure of ramelteon was 31% higher, the maximum serum concentration (Cmax) was 22% lower, and the median time to the maximum serum concentration (Tmax) was 45 minutes longer as compared with the fasted state. Similar effects were noted with the pharmacokinetics of the active metabolite, M-II. In addition, ramelteon should likely not be taken with grapefruit juice; grapefruit juice might increase the risk for ramelteon side effects. Ramelteon is a high extraction ratio drug, and grapefruit inhibits enteric CYP3A4 activity.

<b>DISCLAIMER:</b><em> This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.</em>