New and emerging pharmacotherapeutic approaches for insomnia

References

• Abbott Laboratories. (2006). ProSom prescribing information.
   Google Scholar
• Ancoli-Israel, S., Richardson, G.S., Mangano, R.M., Jenkins, L., Hall, P., & Jones, W.S. (2005). Long-term use of sedative hypnotics in older patients with insomnia. Sleep Medicine, 6, 107–113. doi:S1389-9457(04)00207-2 [pii]; 10.1016/j.sleep. 2004.10.015 [doi]
   PubMed Web of Science ®Google Scholar
• APA (American Psychiatric Association). (2013). Diagnostic and Statistical Manual of Mental Disorders (5th ed.) Arlington, VA: American Psychiatric Association.
   Google Scholar
• Aurora, R.N., Zak, R.S., Auerbach, S.H., Casey, K.R., Chowdhuri, S., Karippot, A., ... American Academy of Sleep Medicine. (2010). Best practice guide for the treatment of nightmare disorder in adults. Journal of Clinical Sleep Medicine, 6, 389–401.
   PubMed Web of Science ®Google Scholar
• Avidan, A.Y., Fries, B.E., James, M.L., Szafara, K.L., Wright, G.T., & Chervin, R.D. (2005). Insomnia and hypnotic use, recorded in the minimum data set, as predictors of falls and hip fractures in Michigan nursing homes. Journal of the American Geriatrics Society, 53, 955–962. doi:JGS53304 [pii]; 10.1111/ j.1532-5415.2005.53304.x [doi]
   PubMed Web of Science ®Google Scholar
• Avram, M.J., Spyker, D.A., Kehne, J.H., & Cassella, J.V. (2013). The pharmacokinetics and pharmacodynamics of zaleplon delivered as a thermally generated aerosol in a single breath to volunteers. Journal of Clinical Pharmacology, doi:10.1177/009 1270011436886; 10.1177/0091270011436886
   Google Scholar
• Barrett, J.R., Tracy, D.K., & Giaroli, G. (2013). To sleep or not to sleep: A systematic review of the literature of pharmacological treatments of insomnia in children and adolescents with attention-deficit/hyperactivity disorder. Journal of Child and Adolescent Psychopharmacology, 23, 640–647. doi:10.1089/cap.2013.0059; 10.1089/cap.2013.0059
   PubMed Web of Science ®Google Scholar
• Bateson, A.N. (2006). Further potential of the GABA receptor in the treatment of insomnia. Sleep Medicine, doi: S1389-9457(06)00066-9 [pii]; 10.1016/j.sleep.2006.03.001 [doi]
   Google Scholar
• Betschart, C., Hintermann, S., Behnke, D., Cotesta, S., Fendt, M., Gee, C.E., Hoyer, D. (2013). Identification of a novel series of orexin receptor antagonists with a distinct effect on sleep architecture for the treatment of insomnia. Journal of Medicinal Chemistry, doi: 10.1021/jm4007627
   Google Scholar
• Brassington, G.S., King, A.C., & Bliwise, D.L. (2000). Sleep problems as a risk factor for falls in a sample of community-dwelling adults aged 64–99 years. Journal of the American Geriatrics Society, 48, 1234–1240.
   PubMed Web of Science ®Google Scholar
• Brisbare-Roch, C., Dingemanse, J., Koberstein, R., Hoever, P., Aissaoui, H., Flores, S., ... Jenck, F. (2007). Promotion of sleep by targeting the orexin system in rats, dogs and humans. Nature Medicine, 13, 150–155. doi:10.1038/nm1544
   PubMed Web of Science ®Google Scholar
• Buscemi, N., Vandermeer, B., Friesen, C., Bialy, L., Tubman, M., Ospina, M., ... Witmans, M. (2007). The efficacy and safety of drug treatments for chronic insomnia in adults: A meta-analysis of RCTs. Journal of General Internal Medicine, 22, 1335–1350. doi:10.1007/s11606-007-0251-z
   PubMed Web of Science ®Google Scholar
• Buysse, D.J., & Ganguli, M. (2002). Can sleep be bad for you? Can insomnia be good?Archives of General Psychiatry, 59, 137–138.
   PubMed Web of Science ®Google Scholar
• de Lecea, L., Kilduff, T.S., Peyron, C., Gao, X., Foye, P.E., Danielson, P.E., ... Sutcliffe, J.G. (1998). The hypocretins: Hypothalamus-specific peptides with neuroexcitatory activity. Proceedings of the National Academy of Sciences of the United States of America, 95, 322–327.
   PubMed Web of Science ®Google Scholar
• ECR Pharmaceuticals. (2010). ZolpiMist prescribing information.
   Google Scholar
• Herring, W.J., Snyder, E., Budd, K., Hutzelmann, J., Snavely, D., Liu, K., ... Michelson, D. (2012). Orexin receptor antagonism for treatment of insomnia: A randomized clinical trial of suvorexant. Neurology, 79, 2265–2274. doi:10.1212/WNL. 0b013e31827688ee; 10.1212/WNL.0b013e31827688ee
   PubMed Web of Science ®Google Scholar
• Hoever, P., Dorffner, G., Benes, H., Penzel, T., Danker-Hopfe, H., Barbanoj, M.J., ... Dingemanse, J. (2012). Orexin receptor antagonism, a new sleep-enabling paradigm: A proof-of-concept clinical trial. Clinical Pharmacology and Therapeutics, 91, 975–985. doi:10.1038/clpt.2011.370; 10.1038/clpt.2011.370
   PubMed Web of Science ®Google Scholar
• Jaussent, I., Ancelin, M.L., Berr, C., Peres, K., Scali, J., Besset, A., ... Dauvilliers, Y. (2013). Hypnotics and mortality in an elderly general population: A 12-year prospective study. BMC Medicine, 11, 212. doi:10.1186/1741-7015-11-212
   Google Scholar
• Kato, K., Hirai, K., Nishiyama, K., Uchikawa, O., Fukatsu, K., Ohkawa, S., ... Miyamoto, M. (2005). Neurochemical properties of ramelteon (TAK-375), a selective MT1/MT2 receptor agonist. Neuropharmacology, 48, 301–310. doi: S0028-3908 (04)00309-0 [pii]; 10.1016/j.neuropharm.2004. 09.007 [doi]
   PubMed Web of Science ®Google Scholar
• King Pharmaceuticals Inc. (2006). Sonata prescribing information.
   Google Scholar
• Kripke, D.F., Garfinkel, L., Wingard, D.L., Klauber, M.R., & Marler, M.R. (2002). Mortality associated with sleep duration and insomnia. Archives of General Psychiatry, 59, 131–136.
   PubMed Web of Science ®Google Scholar
• Kripke, D.F., Langer, R.D., & Kline, L.E. (2012). Hypnotics’ association with mortality or cancer: A matched cohort study. BMJ Open, 2, e000850-2012-000850. Print 2012. doi: 10.1136/bmjopen-2012-000850; 10.1136/bmjopen-2012-000850
   Google Scholar
• Kryger, M., Roth, T., Wang-Weigand, S., & Zhang, J. (2008). The effects of ramelteon on respiration during sleep in subjects with moderate to severe chronic obstructive pulmonary disease. Sleep and Breathing, 13(1), 79–84. doi:10.1007/s11325-008-0196-4
   Google Scholar
• Kryger, M., Wang-Weigand, S., & Roth, T. (2007a). Safety of ramelteon in individuals with mild to moderate obstructive sleep apnea. Sleep & Breathing, 11, 159–164. doi:10.1007/s11325-006-0096-4
   PubMed Web of Science ®Google Scholar
• Kryger, M., Wang-Weigand, S., Zhang, J., & Roth, T. (2007b). Effect of ramelteon, a selective MT(1)/MT (2)-receptor agonist, on respiration during sleep in mild to moderate COPD. Sleep & Breathing, doi:10.1007/s11325-007-0156-4
   Google Scholar
• Krystal, A.D. (2010). Antidepressant and antipsychotic drugs. Sleep Medicine Clinics, 5, 571–589. doi:10.1016/j.jsmc. 2010.08.010
   Google Scholar
• Krystal, A.D., Richelson, E., & Roth, T. (2013). Review of the histamine system and the clinical effects of H1 antagonists: Basis for a new model for understanding the effects of insomnia medications. Sleep Medicine Reviews, 17, 263–272. doi:10.1016/j.smrv.2012.08.001; 10.1016/j.smrv.2012.08.001
   Google Scholar
• Krystal, A.D., Walsh, J.K., Laska, E., Caron, J., Amato, D.A., Wessel, T.C., & Roth, T. (2003). Sustained efficacy of eszopiclone over 6 months of nightly treatment: Results of a randomized, double-blind, placebo-controlled study in adults with chronic insomnia. Sleep, 26, 793–799.
   PubMed Web of Science ®Google Scholar
• Lankford, A., Hull, S., Scharf, M., Schwartz, H., Seiden, D., Jochelson, P., ... Roth, T. (2007). Efficacy and safety of doxepin 3 and 6 mg in adults with primary insomnia [Abstract]. Sleep, 13(2), 133–138.
   Google Scholar
• Lankford, A., Segal, S., Borders, J., Anderson, D., Durrence, H., Rogowski, R., ... Roth, T. (2008). Efficacy and safety of doxepin 6 mg in a 4-week outpatient trial of elderly adults with primary insomnia [Abstract]. Sleep, 31, SA256.
   Google Scholar
• Mahbarg, L. (2013). The Savvy Insomniac: A Personal Journey through Science to Better Sleep. Ann Arbor, MI: Fine Fettle Books.
   Google Scholar
• Meda Pharmaceuticals. (2013). Edluar prescribing information.
   Google Scholar
• Mylan Pharmaceuticals. (2010). Restoril prescribing information.
   Google Scholar
• Neuro Pharma. (2013). Doral prescribing information.
   Google Scholar
• Obayashi, K., Araki, T., Nakamura, K., Kurabayashi, M., Nojima, Y., Hara, K., ... Yamamoto, K. (2013). Risk of falling and hypnotic drugs: Retrospective study of inpatients. Drugs in R & D, 13, 159–164. doi:10.1007/s40268-013-0019-3; 10.1007/s40268-013-0019-3
   Google Scholar
• Ohayon, M.M. (2002). Epidemiology of insomnia: What we know and what we still need to learn. Sleep Medicine Reviews, 6, 97–111.
   PubMed Web of Science ®Google Scholar
• Purdue Pharma. (2012). Intermezzo prescribing information.
   Google Scholar
• Randall, S., Roehrs, T.A., & Roth, T. (2012). Efficacy of eight months of nightly zolpidem: A prospective placebo-controlled study. Sleep, 35, 1551–1557. doi:10.5665/sleep.2208; 10.5665/sleep.2208
   PubMed Web of Science ®Google Scholar
• Raskind, M.A., Peskind, E.R., Hoff, D.J., Hart, K.L., Holmes, H.A., Warren, D., ... McFall, M.E. (2007). A parallel group placebo controlled study of prazosin for trauma nightmares and sleep disturbance in combat veterans with post-traumatic stress disorder. Biological Psychiatry, 61, 928–934. doi:10.1016/j.biopsych.2006.06.032
   PubMed Web of Science ®Google Scholar
• Raskind, M.A., Peterson, K., Williams, T., Hoff, D.J., Hart, K., Holmes, H., ... Peskind, E.R. (2013). A trial of prazosin for combat trauma PTSD with nightmares in active-duty soldiers returned from Iraq and Afghanistan. American Journal of Psychiatry, doi:10.1176/appi.ajp.2013.12081133; 10.1176/appi.ajp.2013.12081133
   Google Scholar
• Richardson, G.S., Roehrs, T.A., Rosenthal, L., Koshorek, G., & Roth, T. (2002). Tolerance to daytime sedative effects of H1 antihistamines. Journal of Clinical Psychopharmacology, 22, 511–515.
   PubMed Web of Science ®Google Scholar
• Roehrs, T., & Roth, T. (2001). Sleep, sleepiness, sleep disorders and alcohol use and abuse. Sleep Medicine Reviews, 5, 287–297. doi:10.1053/smrv.2001.0162.
   PubMed Web of Science ®Google Scholar
• Roth, T., Berglund, P., Shahly, V., Shillington, A.C., Stephenson, J.J., & Kessler, R.C. (2013a). Middle-of-the-night hypnotic use in a large national health plan. Journal of Clinical Sleep Medicine, 9, 661–668. doi:10.5664/jcsm.2832; 10.5664/jcsm.2832
   Google Scholar
• Roth, T., Krystal, A., Steinberg, F.J., Singh, N.N., & Moline, M. (2013b). Novel sublingual low-dose zolpidem tablet reduces latency to sleep onset following spontaneous middle-of-the-night awakening in insomnia in a randomized, double-blind, placebo-controlled, outpatient study. Sleep, 36, 189–196. doi:10.5665/sleep.2370; 10.5665/sleep.2370
   Google Scholar
• Roth, T., Rogowski, R., Hull, S., Schwartz, H., Koshorek, G., Corser, B., ... Lankford, A. (2007). Efficacy and safety of doxepin 1 mg, 3 mg, and 6 mg in adults with primary insomnia. Sleep, 30, 1555–1561.
   PubMed Web of Science ®Google Scholar
• Roth, T., Walsh, J.K., Krystal, A., Wessel, T., & Roehrs, T.A. (2005). An evaluation of the efficacy and safety of eszopiclone over 12 months in patients with chronic primary insomnia. Sleep Medicine, 6, 487–495. doi:S1389-9457(05)00137-1 [pii]; 10.1016/j.sleep.2005.06.004 [doi]
   PubMed Web of Science ®Google Scholar
• Roxane Laboratories. (2012). Halcion prescribing information.
   Google Scholar
• Rudolph, U., & Mohler, H. (2006). GABA-based therapeutic approaches: GABAA receptor subtype functions. Current Opinion in Pharmacology, 6, 18–23. doi:10.1016/j.coph.2005. 10.003
   PubMed Web of Science ®Google Scholar
• Sack, R.L., & Lewy, A.J. (2001). Circadian rhythm sleep disorders: Lessons from the blind. Sleep Medicine Reviews, 5, 189–206. doi:10.1053/smrv.2000.0147
   PubMedGoogle Scholar
• Sakurai, T., Amemiya, A., Ishii, M., Matsuzaki, I., Chemelli, R.M., Tanaka, H., ... Yanagisawa, M. (1998). Orexins and orexin receptors: A family of hypothalamic neuropeptides and G protein-coupled receptors that regulate feeding behavior. Cell, 92, 573–585.
   PubMed Web of Science ®Google Scholar
• Sanofi-Aventis. (2013a). Ambien CR prescribing information.
   Google Scholar
• Sanofi-Aventis. (2013b). Ambien prescribing information.
   Google Scholar
• Saper, C.B. (2013). The central circadian timing system. Current Opinion in Neurobiology, 23, 747–751. doi:10.1016/j.conb.2013.04.004; 10.1016/j.conb.2013.04.004
   PubMed Web of Science ®Google Scholar
• Schutte-Rodin, S., Broch, L., Buysse, D., Dorsey, C., & Sateia, M. (2008). Clinical guideline for the evaluation and management of chronic insomnia in adults. Journal of Clinical Sleep Medicine, 4, 487–504.
   PubMed Web of Science ®Google Scholar
• Somaxon Pharmaceuticals. (2010). Silenor prescribing information.
   Google Scholar
• Sunuvion Pharmaceuticals. (2012). Lunesta prescribing information.
   Google Scholar
• Takeda Pharmaceuticals North America. (2010). Rozerem prescribing information.
   Google Scholar
• Taylor, F.B., Martin, P., Thompson, C., Williams, J., Mellman, T.A., Gross, C., ... Raskind, M.A. (2008). Prazosin effects on objective sleep measures and clinical symptoms in civilian trauma posttraumatic stress disorder: A placebo- controlled study. Biological Psychiatry, 63, 629–632. doi:10.1016/j.biopsych.2007.07.001
   PubMed Web of Science ®Google Scholar
• US FDA. (2013a) FDA requests label change for all sleep disorder drug products. Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108868.htm
   Google Scholar
• US FDA. (2013b). Zolpidem containing products: Drug safety communication – FDA requires lower recommended doses. Retrieved from http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm334738.htm
   Google Scholar
• US FDA Center for Food Safety and Applied Nutrition. (2007). Kava-containing dietary supplements may be associated with severe liver injury. Retrieved from http://www.cfsan.fda.gov/∼dms/addskava.html
   Google Scholar
• van Strien, A.M., Koek, H.L., van Marum, R.J., & Emmelot-Vonk, M.H. (2013). Psychotropic medications, including short acting benzodiazepines, strongly increase the frequency of falls in elderly. Maturitas, 74, 357–362. doi:10.1016/j.maturitas. 2013.01.004; 10.1016/j.maturitas.2013.01.004
   PubMed Web of Science ®Google Scholar
• Vermeeren, A. (2004). Residual effects of hypnotics: Epidemiology and clinical implications. CNS Drugs, 18, 297–328. doi:1853 [pii]
   PubMed Web of Science ®Google Scholar
• Walsh, J.K. (2004). Drugs used to treat insomnia in 2002: Regulatory-based rather than evidence-based medicine. Sleep, 27, 1441–1442.
   PubMed Web of Science ®Google Scholar
• Walsh, J.K., Krystal, A.D., Amato, D.A., Rubens, R., Caron, J., Wessel, T.C., ... Roth, T. (2007). Nightly treatment of primary insomnia with eszopiclone for six months: Effect on sleep, quality of life, and work limitations. Sleep, 30, 959–968.
   PubMed Web of Science ®Google Scholar
• West-Ward Pharmaceutical. (2010). Dalmane prescribing information.
   Google Scholar
• Widera, E. (2013). What's to blame for falls and fractures? Poor sleep or the sleeping medication? Comment on ‘nonbenzodiazepine sleep medication use and hip fractures in nursing home residents’. JAMA Internal Medicine, 173, 761–762. doi:10.1001/jamainternmed.2013.3801; 10.1001/jamainternmed. 2013.3801
   Google Scholar
• Wu, T.Y., Chie, W.C., Yang, R.S., Kuo, K.L., Wong, W.K., & Liaw, C.K. (2013). Risk factors for single and recurrent falls: A prospective study of falls in community dwelling seniors without cognitive impairment. Preventive Medicine, 57, 511–517. doi:10.1016/j.ypmed.2013.07.012; 10.1016/j.ypmed. 2013.07.012
   PubMed Web of Science ®Google Scholar
• Xu, Z., Jiang, X., Li, W., Gao, D., Li, X., & Liu, J. (2011). Propofol-induced sleep: Efficacy and safety in patients with refractory chronic primary insomnia. Cell Biochemistry and Biophysics, 60, 161–166. doi:10.1007/s12013-010-9135-7; 10.1007/s12013-010-9135-7.
   PubMed Web of Science ®Google Scholar
• Zammit, G.K., Corser, B., Doghramji, K., Fry, J.M., James, S., Krystal, A., & Mangano, R.M. (2006). Sleep and residual sedation after administration of zaleplon, zolpidem, and placebo during experimental middle-of-the-night awakening. Journal of Clinical Sleep Medicine, 2, 417–423.
   PubMed Web of Science ®Google Scholar