1. What were the results of the 6-month sleep study?

Rozerem is effective for long-term use, as demonstrated in a 6-month sleep study. The 6-month sleep study found that Rozerem significantly reduced sleep latency through six 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 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 Patients should be advised to avoid engaging in hazardous activities (such as operating a motor vehicle or heavy machinery) after taking Rozerem.⁴

In addition, 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

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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1. How does Rozerem promote sleep?

Rozerem is thought to promote sleep by acting on MT₁ and MT₂ receptors within the SCN.⁸ The SCN is the body’s master clock.⁷ Rozerem selectively binds to MT₁ and MT₂ receptors located throughout the brain.^4,7-10 Binding to MT₁ receptors in the SCN is thought to attenuate the alerting signal from the SCN, which allows sleep load to dominate and wakefulness to subside.^4,7,11,12 Binding to MT₂ receptors in the SCN is thought to maintain the circadian rhythm underlying the normal sleep-wake cycle.^4,7,11 Rozerem has been associated with decreased testosterone levels and increased prolactin levels.

Rozerem promotes sleep, not sedation. Rozerem works with the body’s sleep-wake cycle.⁸ Rozerem does not promote sleep by generalized CNS depression.^4,7,8,11 Patients should avoid engaging in activities requiring complete mental alertness such as operating machinery or driving a motor vehicle after ingesting the drug.⁴

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.

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2. Has Rozerem shown evidence of abuse potential in clinical studies?

No. Rozerem shows zero evidence of abuse potential at up to 20 times the recommended dose.^4,5 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

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1. Can Rozerem be used in older patients?

Yes. Rozerem is an insomnia treatment that addresses certain safety concerns of older patients. In a study, Rozerem did not impair middle-of-the-night balance or memory in older adults.^‡ Rozerem has been associated with decreased testosterone levels and increased prolactin levels.

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. To learn more, read the full profile on older patients.

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2. Can Rozerem be used in patients with mild-to-severe COPD?

Yes. Rozerem can be safely administered to patients with mild-to-severe COPD. Recent studies show that 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 postdose.²⁴ 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 postdose.²³ 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. To learn more, read the full profile on patients with mild-to-severe COPD.

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3. Can Rozerem be used in patients for whom substance abuse is a concern?

Yes. Rozerem provides insomnia treatment with no evidence of potential abuse. In a study, no significant effects on measures of drug abuse potential were observed compared with placebo. In a study of adult subjects with histories of poly-drug abuse, Rozerem showed no significant difference in abuse liability or cognitive (memory)/psychomotor performance versus placebo at any dose tested (even at up to 20 times the recommended dose).⁵ By contrast, triazolam, used as a reference treatment, at the two highest doses showed significant differences compared with placebo, demonstrating a dose-dependent effect.⁵ Patients should be advised not to consume alcohol in combination with Rozerem, as alcohol and Rozerem may have additive effects when used in conjunction.

To learn more, read the full profile on patients for whom substance abuse is a concern.

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4. How does Rozerem address the concerns of patients concerned about waking up "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^‡1-3,20,21 To learn more, read the full profile on patients concerned about waking up "hungover."

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