Ramelteon Has Sustained Efficacy Over Six Months In Adults With Chronic Insomnia
A total of 451 patients age 18 or older with chronic insomnia were randomized in this clinical study. Patients were given a nighttime dose of ramelteon 8 mg or placebo for up to 24 consecutive weeks with assessments performed after week one and months one, three, five and six of treatment.
Study results revealed consistent and statistically significant improvements in time to sleep onset using objective assessment via polysomnography -- a test that records brain activity and other body functions during sleep. Long-term use of ramelteon 8 mg was well tolerated and showed no evidence of next-day residual effects, pharmacological tolerance, rebound insomnia or withdrawal symptoms.
ROZEREM (ramelteon) is indicated for the treatment of insomnia characterized by difficulty with sleep onset. ROZEREM can be prescribed for long-term use. ROZEREM is the first and only prescription sleep medication that has shown no evidence of abuse or dependence in clinical studies, and has not been designated as a controlled substance. With the exception of ROZEREM, all other prescription medications indicated for insomnia are classified as Schedule IV controlled substances by the U.S. Drug Enforcement Administration. ROZEREM has a unique therapeutic mechanism of action that targets two receptors located in the brain's suprachiasmatic nucleus (SCN). The SCN is known as the body's "master clock" because it regulates the sleep- wake cycle. *ROZEREM is not a controlled substance. A clinical abuse liability study showed no differences indicative of abuse potential between ROZEREM and placebo at doses up to 20 times the recommended dose (N=14). Three 35-day insomnia studies showed no evidence of rebound insomnia or withdrawal symptoms with ROZEREM compared to placebo (N=2082).
Important Safety Information
ROZEREM should not be used in patients with hypersensitivity to any components of the formulation, severe hepatic impairment, or in combination with fluvoxamine. Failure of insomnia to remit after a reasonable period of time should be medically evaluated, as this may be the result of an unrecognized underlying medical disorder. Hypnotics should be administered with caution to patients exhibiting signs and symptoms of depression.
ROZEREM has not been studied in patients with severe sleep apnea, severe COPD, or in children or adolescents. The effects in these populations are unknown. Avoid taking ROZEREM with alcohol.
ROZEREM has been associated with decreased testosterone levels and increased prolactin levels. Health professionals should be mindful of any unexplained symptoms possibly associated with such changes in these hormone levels. ROZEREM should not be taken with or immediately after a high-fat meal. ROZEREM should be taken within 30 minutes before going to bed and activities confined to preparing for bed.