Rozerem—Clinical Study Results

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

Rozerem is effective for long-term use, as demonstrated in a 6-month sleep study

Rozerem significantly reduced time to fall asleep through 6 months

In adults and older patients with chronic insomnia, Rozerem reduced latency to persistent sleep (LPS) by 40 minutes (56%) from baseline at Month 6 compared with 30 minutes (43%) in patients receiving placebo^3,6
No rebound insomnia or withdrawal symptoms were observed following the abrupt discontinuation of treatment^3,6
No clinically relevant next-day residual effects were seen with respect to psychomotor performance, memory, mood and feelings, or alertness and concentration when compared to placebo^3,6
Patients should be advised to avoid engaging in hazardous activities (such as operating a motor vehicle or heavy machinery) after taking Rozerem⁴
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 disorder.⁴

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Sleep recordings showed significant reductions in time to fall asleep as early as Night 1

Sleep recordings showed that patients receiving Rozerem experienced a 39-minute (55%) reduction in LPS from baseline on Nights 1 and 2 compared with 23 minutes (33%) in patients receiving placebo^3,6

For Week 1 measurement sleep was evaluated by polysomnography and morning questionnaires on the first 2 nights

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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.

§Results of a randomized, double-blind, placebo-controlled, 6-month study (N=451) in adults (18–79 years) with chronic insomnia. Objective sleep latency was evaluated by polysomnography on the first 2 consecutive nights of Week 1, the last 2 nights of Months 1, 3, 5, and 6, and Week 1 of the 2-week, single-blind, placebo run-out.^3,6

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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.