Newswise — A new study presented today showed that the sleep medication Rozerem (ramelteon) did not exacerbate respiratory depressant effects in patients (40 years and older) with moderate to severe chronic obstructive pulmonary disease (COPD), as measured by oxygenation or abnormal breathing events relative to placebo. Results of this double-blind, placebo-controlled trial were presented at the 53rd International Respiratory Congress of the American Association for Respiratory Care.

“Getting adequate sleep is essential to maintaining health in people who live with COPD. These results suggest that ramelteon is a sleep medication that can be used safely in adults suffering from moderate to severe COPD who are concerned with breathing impairment during sleep,” said Thomas Roth, PhD, director, Henry Ford Sleep Research and Disorders Center. “While traditional sleep aids can negatively affect respiration during sleep in patients with COPD, this study demonstrated that ramelteon does not produce such respiratory depressant effects.”

According to the National Institutes of Health, more than 12 million Americans are currently diagnosed with COPD. It is the fourth leading cause of death in the United States and causes serious, long-term disability.

“Patients with COPD – usually characterized by a combination of chronic bronchitis and emphysema – must take extreme care in ensuring they receive enough oxygen at all times, particularly when sleeping. Other medications used for insomnia may reduce upper airway muscle tone, which can lead to increased hypoxemia,” said Dr. Roth. “This study shows that there was no difference in blood oxygen saturation all night between placebo and ramelteon.”

Study results showed:

•Compared with placebo, there was no statistically significant difference in the number of minutes in the night that SaO2 was <80% and <90% (P=0.927 and P=0.653, respectively).
•The mean apnea-hypopnea index was similar between ramelteon and placebo (P=0.804).
•A significant increase in total sleep time (389.0 vs 348.4 min, P=0.019) and sleep efficiency (81.0 vs 72.6%, P=0.019) was observed with ramelteon vs placebo.
•Latency to persistent sleep was shorter with ramelteon vs placebo (23.1 vs 56.9 min) (P=0.051).
•Adverse events were reported in four patients with ramelteon and four patients with placebo treatment; none was noted as serious or led to study discontinuation.

People with COPD have few options for treating insomnia because the traditional sleep medications cause a sedative effect that can further depress respiration. “This study is important in helping us understand the effects of ramelteon in patients with moderate to severe COPD,” said Louis J. Mini, MD, medical director, Neuroscience, Takeda Pharmaceuticals North America, Inc. “COPD is a common disorder seen in clinical practice, and studies of this type provide useful information for physicians treating this population.”

Ramelteon 8 mg is currently marketed as ROZEREM™. ROZEREM 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 melatonin MT1 and MT2 receptors. The activity at MT1 and MT2 receptors in the suprachiasmatic nucleus (SCN) is thought to promote sleep.

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).

ROZEREM™ should not be used in patients with hypersensitivity to any components of the formulation, severe hepatic impairment, or in combination with fluvoxamine. ROZEREM has been associated with decreased testosterone levels and increased prolactin levels. Health professionals should be mindful of any unexplained symptoms which could include cessation of menses or galactorrhea in females, decreased libido or problems with fertility that are 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. The most common adverse events seen with ROZEREM that had at least a 2% incidence difference from placebo were somnolence, dizziness, and fatigue.