Rozerem—Profiles of Patients with Insomnia

The Patient with
Mild-to-Severe COPD

Meet Jeffrey B.

65-year-old former smoker diagnosed with chronic
bronchitis 3 years ago
Complains of insomnia that includes trouble falling asleep
Concerned about breathing impairment during sleep

Rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep onset.

Rozerem can be administered to patients with mild-to-severe COPD

Mean oxygen saturation (SaO₂) did not worsen throughout the night in patients with moderate-to-severe COPD

In a study of 25 patients with moderate-to-severe COPD, no overall statistically significant difference in mean percent SaO₂ was observed in patients receiving Rozerem 8 mg compared with placebo over the 8 hours postdose²⁴
Similarly, in a separate study of 26 patients with mild-to-moderate COPD, Rozerem 16 mg (twice the recommended dose) and placebo had similar effects on mean percent SaO₂ over the 8 hours postdose²³
The percentage of the night that SaO₂ was <90% was similar for Rozerem and placebo in patients with mild, moderate, and severe COPD^23,24
There is no available information on the respiratory effects of multiple doses of Rozerem in patients with COPD. The respiratory depressant effects in patients with COPD cannot be definitively known from this study

Important Safety Information

In rare cases, severe anaphylactic and anaphylactoid reactions have occurred following use of Rozerem. Angioedema involving the tongue, glottis, or larynx has been reported. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Reactions may require emergency treatment and may be fatal. Patients who develop such reactions should not be rechallenged.
Rozerem should not be used in patients with severe hepatic impairment or in combination with Luvox^® (fluvoxamine).
Failure of insomnia to remit after 7-10 days, worsening of insomnia, or emergence of new cognitive or behavioral abnormalities should be medically evaluated, as this may be the result of an unrecognized underlying medical/psychiatric disorder.
In primarily depressed patients, worsening of depression, including suicidal ideation and completed suicides, can occur with hypnotics.
Hallucinations, as well as behavioral changes such as bizarre behavior, agitation, and mania, have been reported with Rozerem use. Amnesia, anxiety, and other neuropsychiatric symptoms may also occur unpredictably.
Complex behaviors such as "sleep-driving, making or eating food, talking on the phone, sleep-walking, or engaging in other activities while not fully awake," with amnesia for the event, may occur with use of hypnotics, including Rozerem. The use of alcohol with Rozerem may increase the risk of such behaviors. Discontinuation of Rozerem should be strongly considered for patients who report any complex sleep behavior.
Patients should avoid engaging in hazardous activities that require concentration (such as operating a motor vehicle or heavy machinery) after taking Rozerem.
Rozerem should be taken within 30 minutes before going to bed and activities confined to preparing for bed.
Patients should be advised not to consume alcohol in combination with Rozerem, as alcohol and Rozerem may have additive effects when used in conjunction.
Rozerem has been associated with decreased testosterone levels and increased prolactin levels. Patients may experience cessation of menses or galactorrhea in females, decreased libido, or fertility problems that are possibly associated with such hormone changes.
Rozerem has not been studied in patients with severe sleep apnea, or in children or adolescents. The effects in these populations are unknown.
Rozerem should not be taken with or immediately after a high-fat meal.
The most common adverse reactions (≥3% and more common than with placebo) are somnolence, dizziness, fatigue, nausea, and exacerbated insomnia.

LUVOX^® is a registered trademark of Solvay Pharmaceuticals, Inc.

Go to Full Prescribing Information, including Medication Guide.

View complete list of references.

ROZEREM is a trademark of Takeda Pharmaceutical Company Limited registered with the U. S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

The Patient with Mild-to-Severe COPD

Meet Jeffrey B.

Rozerem can be administered to patients with mild-to-severe COPD

Mean oxygen saturation (SaO2) did not worsen throughout the night in patients with moderate-to-severe COPD

Important Safety Information

The Patient with
Mild-to-Severe COPD

Mean oxygen saturation (SaO₂) did not worsen throughout the night in patients with moderate-to-severe COPD