Ramelteon

Ramelteon Tablets are available as round, yellow, film coated tablets debossed with "I3" on one side and "5" on the other side in the following quantities:

NDC 52817-235-30 Bottles of 30
NDC 52817-235-10 Bottles of 100

Store at 25°C(77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed and protected from moisture and humidity.

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Severe Anaphylactic and Anaphylactoid Reactions

Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with ramelteon. Describe the relevant signs/symptoms and advise seeking immediate medical attention if any such things occur.

Sleep-Driving and other Complex Behaviors

There have been reports of people getting out of bed after taking a sleep medication and driving their cars while not fully awake, often with no memory of the event. If a patient experiences such an episode, it should be reported to his or her doctor immediately, since "sleep-driving" can be dangerous. This behavior is more likely to occur when sleep medications are taken with alcohol or other central nervous system depressants. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sleep medication. As with sleep-driving, patients usually do not remember these events.

Endocrine Effects

Patients should consult their health care providers if they experience one of the following: cessation of menses or galactorrhea in females, decreased libido, or problems with fertility. Describe the relevant signs/symptoms and advise seeking medical attention if any such things occur.

Administration Instructions

Patients should be advised to take Ramelteon Tablets within 30 minutes prior to going to bed and should confine their activities to those necessary to prepare for bed.
Patients should be advised that they should not take Ramelteon Tablets with or immediately after a high-fat meal.
Do not break the tablet; it should be swallowed whole.

Lactation

Advise mothers using Ramelteon Tablets to monitor neonates for signs of somnolence and feeding problems. A lactating woman may consider pumping and discarding breast milk during treatment and for 25 hours after Ramelteon Tablets administration to minimize drug exposure to a breastfed infant [see USE IN SPECIFIC POPULATIONS (8.2)].

Manufactured by:

i3 Pharmaceuticals, LLC

200 Park Avenue, Warminster, PA 18974

Distributed by:

TruPharma, LLC

Tampa, FL 33609

OS005-05, Rev.0122

Revised: 01/2022