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The following safety information outlines important warnings and precautions for the use of ramelteon (Rozerem). Please read them carefully and consult your healthcare provider if you have any questions or concerns.

• Severe Allergic Reactions: Although rare, ramelteon (Rozerem) may cause serious allergic reactions, including swelling of the face, lips, tongue, or throat. Symptoms such as nausea and vomiting can occur, whether after the first dose or after repeated use. Discontinue the medication and seek emergency medical assistance if you experience these symptoms.

• Behavioral Changes and Unusual Thoughts: Some individuals may experience changes in behavior, hallucinations, worsening depression, or suicidal thoughts while taking ramelteon (Rozerem). Activities such as driving, cooking, eating, and making phone calls may be performed unconsciously during sleep. If such occurrences happen, consult your healthcare provider immediately, as discontinuation of the medication may be necessary. The risk may increase when combined with alcohol, other CNS depressants, or if there is a history of depression.

• Persistent Insomnia: If insomnia persists or worsens after 7 to 10 days of treatment, it could be due to another underlying condition. Discuss with your healthcare provider to reassess the cause and explore appropriate treatments.

• Driving and Operating Machinery: Since ramelteon (Rozerem) is intended to assist with sleep, refrain from driving or engaging in activities that require concentration after taking the medication. Administer the dose at least 30 minutes prior to bedtime and only when you are ready to sleep. Continue to avoid hazardous activities until you are fully alert.

• Hormonal Changes: The use of ramelteon (Rozerem) may lead to hormonal changes, such as reduced testosterone levels and increased prolactin levels. It is uncertain whether these changes have significant physical effects. Discuss any concerns with your prescriber.

Contraindications: Do not use ramelteon (Rozerem) if you are taking fluvoxamine, as this combination can pose serious health risks. Consult your healthcare provider for further guidance.

Common side effects:

• Dizziness
• Daytime drowsiness
• Tiredness
• Nausea
• Worsening insomnia
• Headaches

Less common but important to monitor:

• Decreased sexual desire
• Missed menstrual periods
• Nipple discharge
• Difficulty becoming pregnant

Serious side effects:

• Severe allergic reactions
• Severe dizziness
• Trouble breathing
• Mental or mood changes
• Depression
• Strange thoughts
• Suicidal thoughts or behaviors
• Sleepwalking
• Driving while not fully awake
• Eating while not fully awake
• Talking on the phone while not fully awake

Interactions with high risk of serious adverse effects and should be avoided:

• Calcium Oxybate
• Fluvoxamine
• Magnesium Oxybate
• Potassium Oxybate
• Sodium Oxybate
• Viloxazine

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Alfentanil
• Alprazolam
• Codeine
• Hydrocodone
• Zolpidem
• Donepezil
• Doxepin
• Fluconazole
• Ketoconazole
• Benzhydrocodone
• Bromazepam
• Bromopride
• Buprenorphine
• Butorphanol
• Cannabidiol
• Capmatinib
• Carbinoxamine
• Cetirizine
• Clobazam
• Dihydrocodeine
• Doxylamine
• Esketamine
• Fentanyl
• Flibanserin
• Fospropofol
• Gabapentin
• GabapentinEnacarbil
• Givosiran
• Hydromorphone
• Ketamine
• Lemborexant
• Levocetirizine
• Levorphanol
• Lofexidine
• Loxapine
• Meclizine
• Meperidine
• Methadone
• Metoclopramide
• Midazolam
• Morphine
• MorphineSulfate Liposome
• Nalbuphine
• Oxycodone
• Oxymorphone
• Pentazocine
• Periciazine
• Pregabalin
• Propofol
• Remifentanil
• Remimazolam
• Scopolamine
• Sufentanil
• Tapentadol
• Tramadol
• Trazodone