Rozerem—Profiles of Patients with Insomnia

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

Are These Your Patients?

Your patients with insomnia have different sleep difficulties and different needs. Read the results of patient studies to learn how Rozerem can be a safe, effective insomnia treatment for patients with the following safety concerns.

The Older Patient

Concerned about losing her balance as she ages and forgetting things due to her sleep medication. There is no information on the effect of multiple dosing. A single nighttime dose of Rozerem 8 mg did not impair middle-of-the-night balance, mobility, or memory functions relative to placebo. The effects on night balance in the elderly cannot be definitively known from this study.^4,22

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The Patient with Mild-to-Severe COPD

Concerned about worsening breathing impairment during sleep. Rozerem did not worsen mean oxygen saturation levels for the entire night compared with placebo. 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.^{†‡ 23,24}

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The Patient for whom Substance Abuse is a Concern

Worried about sleep medications because he wants to avoid medications with abuse potential.^*

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The Patient Concerned about Waking Up "Hungover"

Worried about feeling "hungover" the next day and becoming dependent. Patients should be advised to avoid engaging in hazardous activities (such as operating a motor vehicle or heavy machinery) after taking Rozerem.⁴

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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.

*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). Insomnia studies up to 6 months showed no evidence of rebound insomnia or withdrawal symptoms with Rozerem compared to placebo (N=2533).^4,5

†Results of a randomized, double-blind, placebo-controlled, crossover study of Rozerem 8 mg to evaluate the effect on mean SaO₂ for the entire night in adults (≥40 years) with moderate-to-severe chronic obstructive pulmonary disease (COPD) (N=25).²⁴

‡In a study of 26 patients with mild to moderate COPD, Rozerem 16 mg (twice the recommended dose) and placebo had similar effects on mean SaO₂ over the 8 hours post dose.²³

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.