Rozerem—Profiles of Patients with Insomnia

The Older Patient

Meet Rose T.

67-year-old retiree
Has had difficulty falling asleep for months
As she ages, she worries about losing her balance
Concerned about forgetting things due to her sleep medication

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

Insomnia treatment that addresses the following common safety concerns of older patients

Rozerem did not impair middle-of-the-night balance or memory in older adults^‡

Rozerem 8 mg was not significantly different from placebo on tests assessing middle-of-the-night balance and mobility^4,22
Zolpidem (used as a positive control) significantly impaired performance on tests assessing balance and mobility, when compared with placebo^4,22
Rozerem 8 mg did not significantly affect immediate or delayed recall compared with placebo^4,22
Zolpidem significantly impaired immediate recall but did not affect delayed recall compared with placebo^4,22
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

Patients can wake up without feeling "hungover"

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^‡3,21
Patients should be advised to avoid engaging in hazardous activities (such as operating a motor vehicle or heavy machinery) after taking Rozerem⁴

Rozerem promotes sleep, not sedation

Only Rozerem works with the body's sleep-wake cycle through the melatonin receptor pathway to promote sleep⁸
Rozerem does not promote sleep by generalized CNS depression^4,7,8,11
Rozerem has been shown to decrease testosterone and increase prolactin levels

The SOT protocol objectively identifies abnormalities in postural control and provides an assessment of balance impairment.

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Rozerem demonstrated long-term safety and efficacy in a 6-month sleep study

In adults and older patients, Rozerem reduced LPS by 39 minutes (55%) from baseline on Nights 1 and 2 and by 40 minutes (56%) at 6 months^3,6
No rebound insomnia or withdrawal was observed following the abrupt discontinuation of treatment^3,6
No clinically relevant next-day residual effects were seen with respect to memory, mood and feelings, or alertness and concentration when compared to placebo^3,6
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

Zero evidence of abuse, dependence, or withdrawal^†

Rozerem showed no evidence of abuse potential at up to 20 times the recommended dose^4,5
Rozerem is a prescription insomnia medication that is not categorized as Schedule IV by the Drug Enforcement Administration (DEA)^4,15
No development of tolerance to Rozerem was seen across multiple clinical studies^1,3,4,16
Rozerem has no appreciable affinity for receptors often associated with abuse (eg, GABA, dopamine, opiate)^4,8,17-19
Patients may experience cessation of menses or galactorrhea in females, decreased libido, or fertility problems that are possibly associated with such hormone changes⁴

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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

‡Patients should be advised to avoid engaging in hazardous activities (such as operating a motor vehicle or heavy machinery) after taking Rozerem.⁴

§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

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.