Rozerem—Your Patients and Rozerem

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

Help your patients understand insomnia treatment from Rozerem

Rozerem is non–habit-forming

Clinical studies showed no evidence of potential abuse, dependence, or withdrawal^†

They can wake up without feeling groggy

Across several studies, no clinically relevant next-day residual effects were seen with respect to memory, mood and feelings, or alertness and concentration when compared to placebo^1-3,20,21
Patients should be advised to avoid engaging in hazardous activities (such as operating a motor vehicle or heavy machinery) after taking Rozerem⁴

They are not likely to feel sedated when falling asleep

With Rozerem, falling asleep is achieved by working with the normal sleep-wake cycle, not by generalized CNS depression^4,7,8,11

Rozerem has not been shown to impair balance or memory

In a clinical study, older adults with chronic insomnia who were awakened during the middle of the night were not shown to have impaired balance or memory with Rozerem relative to placebo²²
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

Talk to your patients about what to expect with long-term treatment with Rozerem

Giving patients a clear understanding of what to expect is an important part of Rozerem therapy. Encourage your patients to visit Rozerem.com for more information on how Rozerem works and why it’s different, and for a variety of other valuable sleep resources
Rozerem demonstrated efficacy and safety in a 6-month study³
Failure of insomnia to remit after 7-10 days, worsening of insomnia, or the emergence of new cognitive or behavioral abnormalities should be medically evaluated, as this may be the result of an unrecognized underlying medical/psychiatric disorder⁴

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

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.