Rozerem—Profiles of Patients with Insomnia

The Patient for whom Substance
Abuse is a Concern

Meet Randy E.

45-year-old with history of alcohol and sedative abuse
Substance abuse–free for the past 5 years
Has trouble sleeping that includes difficulty falling asleep

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

Rozerem provides insomnia treatment with no evidence of potential abuse

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 effect⁵

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

The two higher doses of triazolam were rated significantly greater than placebo. No dose of Rozerem was significantly different from placebo.

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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

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.