Demonstrated
efficacy in adults
and older patients

ROZEREM dosing

  • The recommended dose of ROZEREM (ramelteon) is 8 mg QD, taken within 30 minutes of going to bed. It is recommended that ROZEREM (ramelteon) not be taken with or immediately after a high-fat meal. The total ROZEREM (ramelteon) dose should not exceed 8 mg per day2

  • ROZEREM should not be used in patients with severe hepatic impairment, or in combination with Luvox® (fluvoxamine). ROZEREM should be used with caution in patients with moderate hepatic impairment and in patients taking other CYP1A2 inhibiting drugs2

ROZEREM reduced latency to persistent sleep in short‑term studies

In patients ages 18 to 64 years

  • In a randomized, double-blind, 35-day study of younger adults (aged 18 to 64 years, inclusive) with chronic insomnia, ROZEREM reduced the average latency to persistent sleep (LPS) when compared with placebo as measured by polysomnography (PSG) on the first 2 nights in each of Weeks 1, 3, and 52

In older adults ages 65 and older

  • In a randomized, double-blind, 3-period crossover study in elderly patients (aged 65 and older) with a history of chronic insomnia, ROZEREM reduced LPS as measured by PSG when compared to placebo for 2 consecutive nights in each of the 3 study periods2
  • A 5-week, double-blind, parallel-group study showed that elderly outpatients (aged ≥65 years) with chronic insomnia who received either ROZEREM 4 mg or 8 mg reported reduced time to fall asleep compared with placebo2*

*A similarly designed study performed in younger adults (aged 18-64 years) using 8 mg and 16 mg of ROZEREM did not replicate this finding of reduced patient-reported sleep latency compared to placebo.

ROZEREM significantly reduced time to fall asleep through 6 months

Monthly sleep chart

Monthly sleep chart

  • In a randomized, double-blind, placebo‑controlled, 6 month study, sleep latency was evaluated by PSG in adults (aged 18 to 79 years) with chronic insomnia on the first 2 consecutive nights of Week 1, the last 2 nights of Months 1, 3, 5, and 6, and on the first 2 nights of the 2-week, single-blind, placebo run-out3
  • ROZEREM reduced sleep latency at each time point when compared to placebo. ROZEREM reduced LPS by 40 minutes from baseline at Month 6 compared with 30 minutes in patients receiving placebo3
  • 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 disorder2
  • No rebound insomnia or withdrawal symptoms were observed following the abrupt discontinuation of treatment in studies up to 6 months2

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 reduction in LPS from baseline on Nights 1 and 2 compared with 23 minutes in patients receiving placebo4

Baseline chart

Baseline chart

*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

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The American Geriatrics Society (AGS) Beers Criteria

The American Geriatrics Society (AGS) Beers Criteria

Guidelines for choosing medication for older patients.1

Learn More

Payer Coverage Tool

Payer Coverage Tool

ROZEREM is covered in 7 out of 10 Medicare Part D plans nationwide.*

*Fingertip Formulary, April 2017.

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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.
  • 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.

  1. 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.
  2. Rozerem package insert, Takeda Pharmaceuticals America, Inc.
  3. 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 insomia. Sleep. 2009;32:351-360.
  4. Data on file, Takeda Pharmaceuticals U.S.A., Inc.
  5. 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.
  6. Rudolph U, Crestani F, Benke D, et al. Benzodiazepine actions mediated by specific g-aminobutyric acidA receptor subtypes. Nature. 1999;401:796-800.
  7. Dubocovich ML, Rivera-Bermúdez MA, Gerdin MJ, Masana MI. Molecular pharmacology, regulation and function of mammalian melatonin receptors. Front Biosci. 2003; 8:d1093-d1108.
  8. Ekmekcioglu C. Melatonin receptors in humans: biological role and clinical relevance. Biomed Pharmacother. 2006;60:97-108.
  9. Hummel M, Unterwald EM. D1 dopamine receptor: a putative neurochemical and behavioral link to cocaine action. J Cell Physiol. 2002;191:17-27.
  10. Malcolm RJ. GABA systems, benzodiazepines, and substance dependence. J Clin Psychiatry. 2003;64(suppl 3):36-40.
  11. Nestler EJ. Historical review: molecular and cellular mechanisms of opiate and cocaine addiction. Trends Pharmacol Sci. 2004;25:210-218.
  12. US Dept of Justice. Controlled Substances. Drug Enforcement Administration website. Available at: http://www.deadiversion.usdoj.gov/schedules/orangebook/orangebook.pdf. Accessed on April 18, 2017.

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.
  • 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.