Putting it in simple terms, insomnia means "trouble sleeping." It is a real medical condition in which you may have one or both of these symptoms: trouble falling asleep or having sleep that is not refreshing, for at least one month and causing significant distress.
ROZEREM is approved for adults having trouble falling asleep from insomnia. ROZEREM can treat insomnia characterized by difficulty falling asleep. For more information, please refer to the Medication Guide.
If you have COPD and fear that your breathing may become depressed as a result of using a sleep aid, consider this: two single-dose studies showed ROZEREM did not worsen breathing for people with mild-to-severe COPD. However, there is no available information on the effects of multiple doses of ROZEREM, and the respiratory depressant effects in patients with COPD cannot be definitively known from this study.
It is recommended that you take 1 pill 30 minutes before you go to bed. Because ROZEREM acts quickly, you should confine your activities to those necessary to prepare for bed, and you should avoid any hazardous activities that require concentration, such as driving or operating heavy machinery, until you know how you will react to ROZEREM.
ROZEREM is not likely to make you feel sedated after you take it. Instead, ROZEREM helps you to sleep by working with your normal sleep-wake cycle. So you may feel like you are gently drifting off to sleep.
ROZEREM is approved for adults having trouble falling asleep from insomnia. Patients are instructed to take ROZEREM a half-hour before bed and then to only do activities related to getting ready for bed.
Until you know how you will react to ROZEREM, you should avoid engaging in hazardous activities such as driving or operating heavy machinery. It's been shown to help people fall asleep fast and wake up without feeling groggy or "hungover".
ROZEREM has not been shown to affect middle-of-the-night balance. In a study in older adults, a single nighttime dose of ROZEREM did not affect middle-of-the-night balance, mobility, or memory. However, there is no available information on the effects of multiple doses of ROZEREM, and the effects on night balance in the elderly cannot be definitively known from this study.
This tool can help you determine if caffeine consumption might be affecting your sleep.
Important Safety Information About ROZEREM
Important Safety Information
If you have an allergic reaction, such as swelling of the tongue or throat, trouble breathing, and nausea and vomiting, contact your doctor immediately, as an airway obstruction due to this reaction could be fatal.
Don't take ROZEREM if you're taking LUVOX® (fluvoxamine) or have severe liver problems.
Talk with your healthcare provider if you have a history of depression, mental illness, or suicidal thoughts. Call your healthcare provider if you have abnormal thoughts or behaviors, or your insomnia worsens or is not better within 7-10 days.
Worsening of depression, suicidal thoughts and completed suicides, hallucinations, and nightmares can occur with ROZEREM.
If you experience sleepwalking, driving, eating, or other behaviors while not fully awake, without remembering the event, contact your doctor immediately. There is a higher chance of these behaviors if you drink alcohol with ROZEREM.
Don't drive or operate machinery until you know how you'll react to ROZEREM.
Take ROZEREM right before bed.
Do not drink alcohol or take other medicines that can make you sleepy when using ROZEREM.
ROZEREM may affect testosterone and prolactin. Consult your doctor if you experience changes in your period, libido, or problems with fertility.
Side effects may include somnolence, dizziness, fatigue, nausea, and exacerbated insomnia.
Use of ROZEREM (ramelteon)
ROZEREM is approved for adults having trouble falling asleep from insomnia.