Pharmacotherapy treatment options for insomnia: A primer for clinicians

International Journal of Molecular Sciences

Volumn 17, Issue 1, 2016, Pages

  Asnis, Gregory M ^a,b   Thomas, Manju ^b   Henderson, Margaret A ^b  

^a ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^b The Anxiety and Depression Clinic   (United States)

Author keywords

Guidelines; Hypnotics; Insomnia; Treatment options

Indexed keywords

ANTICONVULSIVE AGENT; ANTIHISTAMINIC AGENT; ATYPICAL ANTIPSYCHOTIC AGENT; BENZODIAZEPINE; BUTALBITAL; DOXEPIN; ESCITALOPRAM; ESZOPICLONE; RAMELTEON; SECOBARBITAL; SUVOREXANT; ZALEPLON; ZOLPIDEM; HYPNOTIC SEDATIVE AGENT;

ANXIETY DISORDER; ARTICLE; CLOSED ANGLE GLAUCOMA; COGNITIVE THERAPY; COMPARATIVE STUDY; DISEASE ASSOCIATION; DROWSINESS; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERANCE; EFFICACY PARAMETERS; HEART INFARCTION; HEART VENTRICLE CONDUCTION; HUMAN; INSOMNIA; LIFESTYLE; LOW DRUG DOSE; LUNG DISEASE; OUTCOME ASSESSMENT; PARASOMNIA; QUALITY OF LIFE; SLEEP PARAMETERS; SLEEP WALKING; SUICIDE; TREATMENT DURATION; URINE RETENTION; ADULT; AGED; FEMALE; FOOD AND DRUG ADMINISTRATION; MALE; MIDDLE AGED; PRACTICE GUIDELINE; SLEEP INITIATION AND MAINTENANCE DISORDERS; STANDARDS; UNITED STATES; VERY ELDERLY; YOUNG ADULT;

ADULT; AGED; AGED, 80 AND OVER; FEMALE; HUMANS; HYPNOTICS AND SEDATIVES; MALE; MIDDLE AGED; SLEEP INITIATION AND MAINTENANCE DISORDERS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; YOUNG ADULT;

EID: 84953220229     PISSN: 16616596     EISSN: 14220067     Source Type: Journal    
DOI: 10.3390/ijms17010050     Document Type: Article

References (74)

1. National Institutes of Health. National institutes of health state of the science conference statement on manifestations and management of chronic insomnia in adults, June 13–15, 2005. Sleep 2005, 28, 1049–1057.
2. Benca, R.M. Consequences of insomnia and its therapies. J. Clin. Psychiatry 2001, 62, 33–38. [PubMed]
3. Bramoweth, A.D.; Taylor, D.J. Chronic insomnia and health care utilization in young adults. Behav. Sleep Med. 2012, 10, 106–121. [CrossRef] [PubMed]
4. Hublin, C.; Partinen, M.; Koskenvuo, M.; Kaprio, J. Heritability and mortality risk of insomnia-related symptoms: A genetic epidemiologic study in a population-based twin cohort. Sleep 2011, 34, 957–964. [CrossRef] [PubMed]
5. Ohayon, M.M.; Roth, T. Place of chronic insomnia in the course of depressive and anxiety disorders. J. Psychiatr. Res. 2003, 37, 9–15. [CrossRef]
6. Breslau, N.; Roth, T.; Rosenthal, L.; Andeski, P. Sleep disturbances and psychiatric disorders: A longitudinal epidemiological study of young adults. Biol. Psychiatry 1996, 39, 411–418. [CrossRef]
7. Ağargün, M.Y.; Kara, H.; Solmaz, M. Sleep disturbances and suicidal behavior in patients with major depression. J. Clin. Psychiatry 1997, 58, 249–251.
8. McCall, W.V.; Blocker, J.N.; D’Agostino, R.,; Kimball, J.; Boggs, N.; Lasater, B.; Roseenquist, P.B. Insomn iaseverity is an indicator of suicidal ideation during a depression clinical trial. Sleep Med. 2010, 11, 822–827. [CrossRef] [PubMed]
9. Nora, C.; Richter, N.; Juckel, G. Sleep disturbances and suicidality: A common association to look for inclinical practice and preventive care. EPMA J. 2011, 2, 295–307. [CrossRef] [PubMed]
10. Fava, M.; Asnis, G.M.; Shrivastava, R.; Lydiard, B.; Bastani, B.; Sheehan, D.; Roth, T. Zolpidem extended-release improves sleep and next-day symptoms in comorbid insomnia and generalized anxiety disorder. J. Clin. Psychopharmcol. 2009, 29, 222–230. [CrossRef] [PubMed]
11. Pollack, M.; Kinrys, G.; Krystal, A.; McCall, W.V.; Roth, T.; Schaefer, K.; Rubens, R.; Roach, J.; Hua ng, H.; Krishnan, R. Eszopiclone coadministered with escitalopram in patients with insomnia and comorbid generalized anxiety disorder. Arch. Gen. Psychiatry 2008, 65, 551–562. [CrossRef] [PubMed]
12. Spiegel, K.; Tasali, E.; Leproult, R.; van Cauter, E. Effects of poor and short sleep on glucose metabolism and obesity risk. Nat. Rev. Endocrinol. 2009, 5, 253–261. [CrossRef] [PubMed]
13. Roth, T.; Price, J.M.; Amato, D.A.; Rubens, R.P.; Roach, J.M.; Schnitzer, T.J. The effect of eszopiclone in patients with insomnia and coexisting rheumatoid arthritis: A pilot study. Prim. Care Companion J. Clin. Psychiatry 2009, 11, 292–301. [CrossRef] [PubMed]
14. Morin, C.M.; Espie, C.A. Insomnia: A Clinical Guide to Assessment and Treatment; Kluwer Academic/Plenum: New York, NY, USA, 2003.
15. Morin, C.M.; Vallières, A.; Guay, B.; Ivers, H.; Savard, J.; Mérette, C.; Bastien, C.; Baillargeon, L. Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: A randomized controlled trial. JAMA 2009, 301, 2005–2015. [CrossRef] [PubMed]
16. Sutton, E.L. Insomnia. Med. Clin. N. Am. 2014, 98, 565–581. [CrossRef] [PubMed]
17. Riemann, D.; Spiegelhalder, K.; Espie, C.; Pollmächer, T.; Léger, D.; Bassetti, C.; van Someren, E. Chronic insomnia: Clinical and research challenges—An agenda. Pharmacopsychiatry 2011, 44, 1–14. [CrossRef] [PubMed]
18. Buysse, D.J. Insomnia. JAMA 2013, 309, 706–716. [CrossRef] [PubMed]
19. Gauillard, J.; Cheref, S.; Vacherontrystram, M.N.; Martin, J.C. Chloral hydrate: A hypnotic best forgotten? Encephale 2002, 28, 200–204. [PubMed]
20. Mendelson, W. Hypnotic medications: Mechanisms of action and pharmacological effects. In Principles and Practices of Sleep Medicine, 5th ed.; Kryger, M.H., Roth, T., Dement,W.C., Eds.; Elsevier: St. Louis, MO, USA, 2011.
21. PDR network. 2015 Physicians’ Desk Reference, 69th ed.; PDR Network: Montvale, NJ, USA, 2014.
22. Krystal, A.D. A compendium of placebo-controlled trials of the risks/benefits of pharmacological treatments for insomnia: The empirical basis for U.S. clinical practice. Sleep Med. Rev. 2009, 13, 265–274. [CrossRef] [PubMed]
23. Greenblatt, D.J.; Roth, T. Zolpidem for insomnia. Expert Opin. Pharmacother. 2012, 13, 879–893. [CrossRef] [PubMed]
24. Sanofi-Aventis. Ambien® Zolpidem. Available online: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452 (accessed on 1 November 2015).
25. Sunovion Pharmaceuticals, Inc. Lunesta® Ezsopiclone. Available online: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fd047b2b-05a6-4d99-95cb-955f14bf329f (accessed on 1 November 2015).
26. Wyeth Pharmaceuticals. Sonata® Zaleplon. Available online: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c8a6c478-1d05-47b2-c98d-99177395b762 (accessed on 1 November 2015).
27. Sanofi-Aventis. Ambien CR® Zolpidem. Available online: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=40f9a7b1-b57b-4e70-b709-e81705e784a7 (accessed on 1 November 2015).
28. Sanna, E.; Busonero, F.; Talani, G.; Carta, M.; Massa, F.; Peis, M.; Maciacco, E.; Biggio, G. Comparison of the effects of zaleplon, zolpidem, and triazolam at various GABA(A) receptor subtypes. Eur. J. Pharmacol. 2002, 451, 103–110. [CrossRef]
29. Jia, F.; Goldstein, P.A.; Harrison, N.L. The modulation of synaptic GABAA receptors in the thalamus by eszopiclone and zolpidem. J. Pharmacol. Exp. Ther. 2009, 328, 1000–1006. [CrossRef] [PubMed]
30. Rudolph, U.; Crestani, F.; Mohler, H. GABAA receptor subtypes: Dissecting their pharmacological functions. Trends Pharmacol. Sci. 2001, 22, 188–194. [CrossRef]
31. Guidance On the Use of Zaleplon, Zolpidem and Zopiclone for the Short-Term Management of Insomnia. Available online: https://www.nice.org.uk/guidance/ta77 (accessed on 1 November 2015).
32. Buscemi, N.; Vandermeer, B.; Friesen, C.; Bialy, L.; Tubman, M.; Ospina, M.; Klassen, T.P.; Witmans, M. The efficacy and safety of drug treatments for chronic insomnia in adults: A meta-analysis of RCTs. J. Gen. Intern. Med. 2007, 22, 1335–1350. [CrossRef] [PubMed]
33. Meda Pharmaceuticals. Edluar™ Zolpidem. Available online: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a32884d0-85b5-11de-8a39-0800200c9a66 (accessed on 1 November 2015).
34. Transcept Pharmaceuticals, Inc. Intermezzo® Zolpidem. Available online: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=913b6cfe-1fb0-44a8-817a-26374bbce995 (accessed on 1 November 2015).
35. ECR Pharmaceuticals. Zolpimist® Zolpidem. Available online: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2facd90f-7356-44f4-a257-c545de2a53a6 (accessed on 1 November 2015).
36. Muramatsu, R.S.; Litzinger, M.H.; Fisher, E.; Takeshita, J.; Fisher, E.; Takeshita, J. Alternative formulations, delivery methods, and administration options for psychotropic medications in elderly patients with behavioral and psychological symptoms of dementia. Am. J. Geriatr. Pharmacother. 2010, 8, 98–114. [CrossRef] [PubMed]
37. Takeda Pharmaceuticals Ramelteon® Rozerem. Available online: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7a51d289-2013-4d37-adf2-91ea49df7932 (accessed on 1 November 2015).
38. Mets, M.A.; de Vries, J.M.; de Senerpont Domis, L.M.; Volkerts, E.R.; Olivier, B.; Verster, J.C. Next-day effects of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on highway driving performance, memory functioning, psychomotor performance, and mood in healthy adult subjects. Sleep 2011, 34, 1327–1334. [CrossRef] [PubMed]
39. Krystal, A.D.; Durrence, H.H.; Scharf, M.; Jochelson, P.; Rogowski, R.; Ludington, E.; Roth, T. Efficacy and safety of doxepin 1 mg and 3 mg in a 12-week sleep laboratory and outpatient trial of elderly subjects with chronic primary insomnia. Sleep 2010, 33, 1553–1561. [PubMed]
40. Somaxen Pharmaceuticals. Silenor® Doxepin. Available online: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1bec1223-5239-4eb6-a9e8-62444106d2c0 (accessed on 1 November 2015).
41. Krystal, A.D.; Richelson, E.; Roth, T. 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 Med. Rev. 2013, 17, 263–272. [CrossRef] [PubMed]
42. Wu, J.; Chang, F.; Zu, H. Efficacy and safety evaluation of citalopram and doxepin on sleep quality in comorbid insomnia and anxiety disorders. Exp. Ther. Med. 2015, 10, 1303–1308. [CrossRef] [PubMed]
43. Merck Sharp & Dhome Corp. Belsomara® Suvorexant. Available online: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5b72731-1acb-45b7-9c13-290ad12d3951 (accessed on 1 November 2015).
44. Michelson, D.; Snyder, E.; Paradis, E.; Chengan-Liu, M.; Snavely, D.B.; Hutzelmann, J.; Walsh, J.K.; Krystal, J.D.; Benca, R.M.; Cohn, M.; et al. Safety and efficacy of suvorexant during 1-year treatment of insomna with subsequent abrupt treatment discontinuation: A phase 3 randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2014, 13, 461–471. [CrossRef]
45. Citrome, L. Suvorexant for insomnia: A systematic review of the efficacy and safety profile for this newly approved hypnotic—What is the number needed to treat, number needed to harm and likelihood to be helped or harmed? Int. J. Clin. Pract. 2014, 68, 1429–1441. [CrossRef] [PubMed]
46. Buysse, D.J. Clinical pharmacology of other drugs used as hypnotics. In Principles and Practices of Sleep Medicine, 5th ed.; Kryger, M.H., Roth, T., Dement, W.C., Eds.; Elsevier: St. Louis, MO, USA, 2011.
47. Krystal, A.D. Pharmacological treatment: Other medications. In Principles and Practices of Sleep Medicine, 5th ed.; Kryger, M.H., Roth, T., Dement, W.C., Eds.; Elsevier: St. Louis, MO, USA, 2011; pp. 916–930.
48. Glassman, A.H.; Preud’homme, X.A. Review of cardiovascular effects of heterocyclic antidepressants. J. Clin. Psychiatry 1993, 54, 16–22. [PubMed]
49. Jayaram, G.; Rao, P. Safety of trazodone as a sleep agent for inpatients. Psychosomatics 2005, 46, 367–369. [CrossRef] [PubMed]
50. Woolf, A.D.; Erdman, A.R.; Nelson, L.S.; Caravati, M.; Cobaugh, D.J.; Booze, L.L. Tricyclic antidepressant poisoning: An evidence-based consensus guideline for out-of-hospital management. Clin. Toxicol. 2007, 45, 203–233. [CrossRef] [PubMed]
51. Schutte-Rodin, S.; Broch, L.; Buysse, D.; Dorsey, C.; Sateia, M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J. Clin. Sleep Med. 2008, 4, 487–504. [PubMed]
52. Katz, D.A.; McHorney, C.A. Clinical correlates of insomnia in patients with chronic illness. Arch. Int. Med. 1998, 158, 1099–1107. [CrossRef]
53. Mayer, G.; Wang-Weigand, S.; Roth-Schechter, B.; Lehmann, F.; Staner, C.; Partinen, M. Efficacy and safety of 6-month nightly ramelteon administration in adults with chronic primary insomnia. Sleep 2009, 32, 351–360. [PubMed]
54. Roehrs, T.A.; Randall, S.; Harris, E.; Maan, R.; Roth, T. Twelve months of nightly zolpidem does not lead to dose escalation: A prospective placebo-controlled study. Sleep 2011, 34, 207–212. [PubMed]
55. Krystal, A.D.; Erman, M.; Zammit, G.K.; Soubrane, C.; Roth, T. Long-term efficacy and safety of zolpidem extended-release 12.5 mg, administered 3 to 7 nights per week for 24 weeks, in patients with chronic primary insomnia: A 6-month, randomized, double-blind, placebo-controlled, parallel-group, multicenter study. Sleep 2008, 31, 79–90. [PubMed]
56. Roth, T.; Walsh, J.K.; Krystal, A.; Wessel, T.; Roehrs, T.A. An evaluation of the efficacy and safety of eszopiclone over 12 months in patients with chronic primary insomnia. Sleep Med. 2005, 6, 487–495. [CrossRef] [PubMed]
57. Ancoli-Israel, S.; Richardson, G.S.; Mangano, R.M.; Jenkins, L.; Hall, P.; Jones,W.S. Long-term use of sedative hypnotics in older patients with insomnia. Sleep Med. 2005, 6, 107–113. [CrossRef] [PubMed]
58. Leger, D.; Partinen, M.; Hirshkowitz, M.; Chokroverty, S.; Touchette, E.; Hedner, J. Daytime consequences of insomnia symptoms among outpatients in primary care practice: EQUINOX international survey. Sleep Med. 2010, 11, 999–1009. [CrossRef] [PubMed]
59. Brower, K.J.; Conroy, D.A.; Kurth, M.E.; Anderson, B.J.; Stein, M.D. Ramelteon and improved insomnia in alcohol-dependent patients: A case series. J. Clin. Sleep Med. 2011, 7, 274–275. [PubMed]
60. Maher, M.J.; Rego, S.A.; Asnis, G.M. Sleep disturbances in patients with post-traumatic stress disorder: Epidemiology, impact and approaches to management. CNS Drugs 2006, 20, 567–590. [CrossRef] [PubMed]
61. Pollack, M.H.; Hoge, E.A.; Worthington, J.J.; Moshier, S.J.; Weschsler, R.S.; Brandes, M.; Simon, N.M. Eszopiclone for the treatment of posttraumatic stress disorder and associated insomnia: A randomized, double-blind, placebo-controlled trial. J. Clin. Psychiatry 2011, 72, 892–897. [CrossRef] [PubMed]
62. Dieperink, M.E.; Drogemuller, L. Zolpidem for insomnia related to PTSD. Psychiatry Serv. 1999, 50, 421. [CrossRef] [PubMed]
63. Lund, B.C.; Bernardy, N.C.; Alexander, B.; Friedman, M.J. Declining benzodiazepine use in veterans with posttraumatic stress disorder. J. Clin. Psychiatry 2012, 73, 292–296. [CrossRef] [PubMed]
64. Lund, B.C.; Abrams, T.E.; Bernardy, N.C.; Alexander, B.; Friedman, M.J. Benzodiazepine prescribing variation and clinical uncertainty in treating posttraumatic stress disorder. Psychiatry Serv. 2013, 64, 21–27. [CrossRef] [PubMed]
65. Smith, W.T.; Londborg, P.D.; Glaudin, V.; Painter, J.R. Short-term augmentation of fluoxetine with clonazepam in te treatment of depression: A double-blind study. Am. J. Psychiatry 1998, 155, 1339–1345. [CrossRef] [PubMed]
66. Smith, W.T.; Longborg, P.D.; Glaudin, V.; Painter, J.R. Summit research network. Is extended clonazepam cotherapy of fluoxetine effective for outpatients with major depression? J. Affect Disord. 2002, 70, 251–259. [CrossRef]
67. Fava, M.; McCall, W.V.; Krystal, A.; Wessel, T.; Rubens, R.; Caron, J.; Amto, D.; Roth, T. Eszopiclone co-administered with fluoxetine in patients with insomnia coexisting with major depressive disorder. Biol. Psychiatry 2006, 59, 1052–1060. [CrossRef] [PubMed]
68. Fava, M.; Asnis, G.M.; Shrivastava, R.K.; Lydiard, B.; Bastani, B.; Sheehan, D.V.; Roth, T. Improved insmnia symptoms and sleep-related next-day functioning in patients with comorbid major depressive disorder and insomnia following concomitant zolpidem extended-release 12.5 mg and escitalopram treatment: A randomized controlled trial. J. Clin. Psychiatry 2011, 72, 914–928. [CrossRef] [PubMed]
69. Nutt, D. GABAA receptors: Subtypes, regional distribution, and function. J. Clin. Sleep Med. 2006, 2, 7–11.
70. Hoque, R.; Chesson, A.L., Zolpidem-induced sleepwalking, sleep related eating disorder, and sleep-driving: Fluorine-18-flourodeoxyglucose positron emission tomography analysis, and a literature review of other unexpected clinical effects of zolpidem. J. Clin. Sleep Med. 2009, 5, 471–476. [PubMed]
71. Kuehn, B.M. FDA warning: Driving may be impaired the morning following sleeping pill use. JAMA 2013, 309, 645–646. [CrossRef] [PubMed]
72. Kripke, D.F.; Garfinkel, L.; Wingrd, D.L.; Klauber, R.R.; Mailer, M.R. Mortality associated with sleep duration and insomnia. Arch. Gen. Psychiatry 2002, 59, 131–136. [CrossRef] [PubMed]
73. Kripke, D.F.; Langer, R.D. Evidence for harm, comment on “Use of benzodiazepines or benzodiazepine related drugs and the risk of cancer: A population-based case-control study”. Br. J. Clin. Pharmacol. 2014, 78, 186–187. [CrossRef] [PubMed]
74. Jaussent, I.; Ancelin, M.L.; Berr, C.; Peres, K.; Scali, J.; Besset, A.; Dauvilliers, Y. Hypnotics and mortality in an elderly general population: A 12-year prospective study. BMC Med. 2013, 11, 212–222. [CrossRef] [PubMed]