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Safety of ramelteon in individuals with mild to moderate obstructive sleep apnea

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Abstract

Ramelteon is a selective MT1/MT2-receptor agonist indicated for insomnia treatment. Because it has no depressant effects on the nervous system, it is not expected to affect the control of breathing. The potential effects of ramelteon on apneic and hypopneic events and arterial oxygen saturation (SaO2) in individuals with obstructive sleep apnea were assessed. In this double-blind, randomized, crossover study, 26 adults with mild to moderate obstructive sleep apnea received ramelteon 16 mg and placebo for one night each, with a 5- to 12-day washout period between treatments. Treatments were administered 30 min before habitual bedtime. Respiratory effort was monitored using respiratory inductance plethysmography, SaO2 was measured by pulse oximetry, and sleep onset and duration were measured by polysomnography and post-sleep questionnaire. Post-sleep questionnaire also measured next-day residual effects. The primary measure was apnea–hypopnea index. Apnea–hypopnea index was similar in ramelteon and placebo groups (11.4 vs 11.1, respectively; CI = −2.1, 2.6,P = 0.812). Ramelteon had no effect on the number of central, obstructive, or mixed apnea episodes. No significant differences were observed in SaO2 for the entire night between ramelteon and placebo (95.1 vs 94.7%;P = 0.070). Ramelteon did not meaningfully affect sleep when evaluated by polysomnography and post-sleep questionnaire. Compared with placebo, ramelteon had no significant effect on next-day residual effects. Adverse events were reported by three subjects in the ramelteon group: headache (n = 2) and urinary tract infection (n = 1). No adverse events were reported with placebo. Ramelteon was well-tolerated and, as expected, did not worsen sleep apnea when administered to subjects with mild to moderate obstructive sleep apnea.

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References

  1. Smith S, Sullivan K, Hopkins W, Douglas J (2004) Frequency of insomnia reports in patients with obstructive sleep apnoea hypopnea syndrome (OSAHS). Sleep Med 5:449–456

    Article PubMed  Google Scholar 

  2. Krakow B, Melendrez D, Ferreira E, Clark J, Warner TD, Sisley B, Sklar D (2001) Prevalence of insomnia symptoms in patients with sleep-disordered breathing. Chest 120:1923–1929

    Article PubMed CAS  Google Scholar 

  3. Shepertycky MR, Banno K, Kryger MH (2005) Differences between men and women in the clinical presentation of patients diagnosed with obstructive sleep apnea syndrome. Sleep 28;309–314

    PubMed  Google Scholar 

  4. George CF (2000) Perspectives on the management of insomnia in patients with chronic respiratory disorders. Sleep 23(Suppl 1):S31–S35

    PubMed  Google Scholar 

  5. Guilleminault C (1990) Benzodiazepines, breathing, and sleep. Am J Med 88:25S–28S

    Article PubMed CAS  Google Scholar 

  6. Berry RB, Kouchi K, Bower J, Prosise G, Light RW (1995) Triazolam in patients with obstructive sleep apnea. Am J Respir Crit Care Med 151:450–454

    PubMed CAS  Google Scholar 

  7. Kato K, Hirai K, Nishiyama K, Uchikawa O, Fukatsu K, Ohkawa S, Kawamata Y, Hinuma S, Miyamoto M (2005) Neurochemical properties of ramelteon (TAK-375), a selective MT1/MT2 receptor agonist. Neuropharmacology 48:301–310

    Article PubMed CAS  Google Scholar 

  8. Liu C, Weaver DR, Jin X, Shearman LP, Pieschl RL, Gribkoff VK, Reppert SM (1997) Molecular dissection of two distinct actions of melatonin on the suprachiasmatic circadian clock. Neuron 19:91–102

    Article PubMed CAS  Google Scholar 

  9. von Gall C, Stehle JH, Weaver DR (2002) Mammalian melatonin receptors: molecular biology and signal transduction. Cell Tissue Res 309:151–162

    Article  Google Scholar 

  10. Erman M, Seiden D, Zammit G, Sainati S, Zhang J (2006) An efficacy, safety, and dose–response study of ramelteon in patients with chronic primary insomnia. Sleep Med 7:17–24

    Article PubMed  Google Scholar 

  11. Zammit G, Roth T, Erman M, Sainati S, Weigand S, Zhang J (2005) Double-blind, placebo-controlled polysomnography and outpatient trial to evaluate the efficacy and safety of ramelteon in adult patients with chronic insomnia. Sleep 28:A228–A229

    Google Scholar 

  12. Roth T, Seiden D, Sainati S, Wang-Weigand S, Zhang J, Zee P (2006) Effects of ramelteon on patient-reported sleep latency in older adults with chronic insomnia. Sleep Med 7:312–318

    Article PubMed  Google Scholar 

  13. Roth T, Stubbs C, Walsh J (2005) Ramelteon (TAK-375), a selective MT1/MT2-receptor agonist, reduces latency to persistent sleep in a model of transient insomnia related to a novel sleep environment. Sleep 28:303–307

    PubMed  Google Scholar 

  14. Johnson M, Suess P, Griffiths RR (2006) Ramelteon: a novel hypnotic lacking abuse liability and sedative side effects. Arch Gen Psychiatry 63:1149–1157

    Article PubMed CAS  Google Scholar 

  15. Dubocovich ML, Yun K, Al-Ghoul WM, Benloucif S, Masana MI (1998) Selective MT2 melatonin receptor antagonists block melatonin-mediated phase advances of circadian rhythms. FASEB J 12:1211–1220

    PubMed CAS  Google Scholar 

  16. Jin X, von Gall C, Pieschl RL, Gribkoff VK, Stehle JH, Reppert SM, Weaver DR (2003) Targeted disruption of the mouse Mel(1b) melatonin receptor. Mol Cell Biol 23:1054–1060

    Article PubMed CAS  Google Scholar 

  17. Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S (1993) The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med 328:1230–1235

    Article PubMed CAS  Google Scholar 

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Acknowledgements

This study was funded by Takeda Pharmaceutical Company Limited.

Author Financial Disclosure

Meir Kryger, MD: Consultant, Takeda Pharmaceuticals North America, Inc.

Thomas Roth, PhD: Grants and Consultant, Takeda Pharmaceuticals North America, Inc.

Sherry Wang-Weigand, MD, PhD: Employee, Takeda Global Research & Development Center.

Author information

Authors and Affiliations

  1. Gaylord Hospital, Sleep Research and Education, 400 Gaylord Farm Road, Wallingford, CT, 06492, USA

    Meir Kryger

  2. Takeda Global Research and Development Center, Inc., Deerfield, IL, USA

    Sherry Wang-Weigand

  3. Sleep Disorders and Research Center, Henry Ford Hospital, Detroit, MI, USA

    Thomas Roth

Authors
  1. Meir Kryger

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  2. Sherry Wang-Weigand

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  3. Thomas Roth

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Corresponding author

Correspondence toMeir Kryger.

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Kryger, M., Wang-Weigand, S. & Roth, T. Safety of ramelteon in individuals with mild to moderate obstructive sleep apnea.Sleep Breath11, 159–164 (2007). https://doi.org/10.1007/s11325-006-0096-4

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