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

Younger and older adult patients who struggle with falling asleep may benefit from Rozerem

Rozerem could be an option for patients who:

Don't want a sleep aid that leaves them feeling groggy or "hungover" the next day

  • 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 placebo1,2
  • 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 unpredictably2
  • Patients should be advised to avoid engaging in hazardous activities (such as operating a motor vehicle or heavy machinery) after taking Rozerem2
  • 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 behavior2

Don't want to feel sedated when falling asleep

  • Rozerem does not promote sleep by generalized CNS depression2,5,6,9
  • Patients should avoid engaging in hazardous activities that require concentration (such as operating a motor vehicle or heavy machinery) after taking Rozerem2
  • Patients should be advised not to consume alcohol in combination with Rozerem, as alcohol may have additive effects when used in conjunction2

Are concerned that using a sleep aid may lead to dependence

  • Rozerem is not a controlled substance2
  • 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)2,3
  • 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 disorder2

Rozerem is not listed as a high-risk medication for older adults in the AGS Beers Criteria11

  • The American Geriatrics Society (AGS) Beers Criteria (2015) lists potentially inappropriate medications for use in elderly patients.11
  • The criteria are intended to be used as guidelines for identifying medication that may pose a greater risk than benefit when used in older adults.11

Rozerem has an established efficacy profile

  • The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal asessments of sleep latency were performed after 2 days of treatment during the crossover study (elderly only), at 5 weeks in the 6-week studies (adults and elderly), and at the end of the 6-month study (adults and elderly).2

Geriatric use of Rozerem

  • A total of 654 subjects in double-blind, placebo-controlled, efficacy trials who received Rozerem were at least 65 years of age; of these, 199 were 75 years of age or older. No overall differences in safety or efficacy were observed between elderly and younger adult subjects.2
  • A double-blind, randomized, placebo-controlled study in elderly subjects with insomnia (n=33) evaluated the effect of a single dose of Rozerem on balance, mobility, and memory fuctions after middle of the night awakening. There is no information on the effect of multiple dosing. Nighttime dosing 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.2

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Important Safety Information for Rozerem (ramelteon)

  • 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 and is not recommended for use in this population.
  • Safety and effectiveness of Rozerem in pediatric patients have not been established.
  • 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.

Indication

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


Please see Full Prescribing Information and Medication Guide for Rozerem.

Show references

  1. Mayer G, Wang-Weigand S, Roth-Schechter B, Lehmann R, Staner C, Partinen M. Efficacy and safety of 6-month nightly ramelteon administration in adults with chronic, primary insomnia. Sleep. 2009;32:351-360.
  2. Rozerem package insert, Takeda Pharmaceuticals America, Inc.
  3. Johnson MW, Suess PE, Griffiths RR. Ramelteon: a novel hypnotic lacking abuse liability and sedative adverse effects. Arch Gen Psychiatry. 2006;63:1149-1157.
  4. Data on file, Takeda Pharmaceuticals U.S.A., Inc.
  5. Dubocovich ML, Rivera-Bermúdez MA, Gerdin MJ, Masana MI. Molecular pharmacology, regulation and function of mammalian melatonin receptors. Front Biosci. 2003;8:d1093-d1108.
  6. Kato K, Hirai K, Nishiyama K, et al. Neurochemical properties of ramelteon (TAK-375), a selective MT1/MT2 receptor agonist. Neuropharmacology. 2005;48:301-310.
  7. Ekmekcioglu C. Melatonin receptors in humans: biological role and clinical relevance. Biomed Pharmacother. 2006;60:97-108.
  8. Dubocovich ML, Benloucif S, Masana MI. Melatonin receptors in the mammalian suprachiasmatic nucleus. Behav Brain Res. 1996;73:141-147.
  9. Liu C, Weaver DR, Jin X, et al. Molecular dissection of two distinct actions of melatonin on the suprachiasmatic circadian clock. Neuron. 1997;19:91-102.
  10. Lavie P. Sleep-wake as a biological rhythm. Annu Rev Psychol. 2001;52:277-303.
  11. The American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2015;63:2227-2246.
  12. Roth T, Seiden D, Sainati S, et. Al. Effects of ramelteon on patient-reported sleep latency in older adults with chronic insomnia. Sleep Med. 2006;7:312-318.
  13. US Dept of Justice. Controlled Substances. Drug Enforcement Administration website. Available at:
    http://www.deadiversion.usdoj.gov/schedules/orangebook/orangebook.pdf. Accessed on September 22, 2016.
  14. Kryger M, Wang-Weigand S, Zhang J, Roth T. Effect of ramelteon, a selective MT(1)/MT(2)-receptor agonist, on respiration during sleep in mild to moderate COPD. Sleep Breath. 2008;12:243-250.
  15. Hummel M, Unterwald EM. D1 dopamine receptor: a putative neurochemical and behavioral link to cocaine action. J Cell Physiol. 2002;191:17-27.
  16. Malcolm RJ. GABA systems, benzodiazepines, and substance dependence. J Clin Psychiatry. 2003;64(suppl 3):36-40.
  17. Nestler EJ. Historical review: molecular and cellular mechanisms of opiate and cocaine addiction. Trends Pharmacol Sci. 2004;25:210-218.
  18. Rudolph U, Crestani F, Benke D, et al. Benzodiazepine actions mediated by specific g-aminobutyric acidA receptor subtypes. Nature. 1999;401:796-800.
  19. Rowlett JK, Platt DM, Lelas S, Atack JR, Dawson GR. Different GABAA receptor subtypes mediate the anxiolytic, abuse-related, and motor effects of benzodiazepine-like drugs in primates. Proc Natl Acad Sci U S A. 2005;102(suppl 3):915-920.
  20. Landolt HP, Gillin JC. GABAA1a receptors: involvement in sleep regulation and potential of selective agonists in the treatment of insomnia. CNS Drugs. 2000;13:185-199.
  21. Kryger M, Roth T, Wang-Weigand S, Zhang J. The effects of ramelteon on respiration during sleep in subjects with moderate to severe chronic obstructive pulmonary disease. Sleep Breath. 2009;13:79-84.

Important Safety Information for Rozerem (ramelteon)

Important Safety Information for Rozerem (ramelteon)

  • 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 and is not recommended for use in this population.
  • Safety and effectiveness of Rozerem in pediatric patients have not been established.
  • 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.

Indication

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


Please see Full Prescribing Information and Medication Guide for Rozerem.