RAMELTEON (Generic for ROZEREM)

Ramelteon 8mg, Oral tablet

Cannabis

· Severity: Major

· Notes for Consumers: Discuss cannabis use with your care team. The effects of your medication may be altered if used with cannabis. Call emergency services right away if you experience slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, or trouble staying awake.

· Notes for Professionals: Advise patients to avoid cannabis use while taking CNS depressants due to the risk for additive CNS depression and potential for other cognitive adverse reactions.

Ramelteon 8mg, Oral tablet

Alcohol

· Severity: Major

· Notes for Consumers: Do not drink alcohol while taking this medication. Drinking alcohol while taking this medication can cause serious side effects, such as central nervous system (CNS) depression, and can increase the risk of falling. Call emergency services right away if you experience symptoms of CNS depression: slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake.

· Notes for Professionals: Advise patients to avoid alcohol consumption while taking CNS depressants. Alcohol consumption may result in additive CNS depression.

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

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>