Efficacy and safety of doxepin 6mg in a four-week outpatient trial of elderly adults with chronic primary insomnia

Sleep Medicine

Volumn 13, Issue 2, 2012, Pages 133-138

  Lankford, Alan ^a   Rogowski, Roberta ^b   Essink, Beal ^c   Ludington, Elizabeth ^b   Heith Durrence, H ^b   Roth, Thomas ^d  

^a Sleep Disorders Center of Georgia   (United States)

^b Somaxon Pharmaceuticals   (United States)

^c Oregon Center Clinical Investigation   (United States)

^d HENRY FORD HOSPITAL   (United States)

Author keywords

Chronic insomnia; Elderly adults; Histamine H 1 receptor antagonist; Low dose doxepin; Sleep maintenance insomnia; Wake time after sleep onset

Indexed keywords

DOXEPIN; PLACEBO;

ADULT; AGED; ARTICLE; CHRONIC PRIMARY INSOMNIA; CLINICAL GLOBAL IMPRESSION SCALE; CONTROLLED STUDY; DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS; DIARRHEA; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; EVENING DOSAGE; FALLING; FEMALE; HUMAN; INSOMNIA; INSOMNIA SEVERITY INDEX; LACERATION; LATENCY TO SLEEP ONSET; MAJOR CLINICAL STUDY; MALE; MEMORY DISORDER; OUTPATIENT CARE; PATIENT GLOBAL IMPRESSION SCALE; PERIPHERAL EDEMA; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; SEDATION; SELF REPORT; SIDE EFFECT; SLEEP PARAMETERS; SLEEP QUALITY; SOMNOLENCE; SUBJECTIVE TOTAL SLEEP TIME; SUBJECTIVE WAKE AFTER SLEEP ONSET; UPPER RESPIRATORY TRACT INFECTION; XEROSTOMIA;

AGED; AGED, 80 AND OVER; CHRONIC DISEASE; DOXEPIN; FEMALE; HISTAMINE H1 ANTAGONISTS; HUMANS; MALE; MIDDLE AGED; OUTPATIENTS; PLACEBOS; SLEEP; SLEEP INITIATION AND MAINTENANCE DISORDERS; TREATMENT OUTCOME;

EID: 84856474088     PISSN: 13899457     EISSN: 18785506     Source Type: Journal    
DOI: 10.1016/j.sleep.2011.09.006     Document Type: Article

References (22)

1. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, D.C.: American Psychiatric Association; 2000: 599-604.
2. Lichstein K.L., Durrence H.H., Taylor D.J., et al. Epidemiology of Sleep: Age, Gender, Ethnicity 2004, Erlbam, Mahwah, NJ.
3. Drake C.L., Roehrs T., Roth T. Insomnia causes, consequences, and therapeutics: an overview. Depress Anxiety 2003, 18:163-176.
4. Janson C., Lindberg E., Gislason T., Elmasry A., Boman G. Insomnia in men-a 10-year prospective population based study. Sleep 2001, 24:425-430.
5. Ohayon M.M. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev 2002, 6:97-111.
6. Foley D., Ancoli-Israel S., Britz P., et al. Sleep disturbances and chronic disease in older adults - Results of the 2003 National Sleep Foundation Sleep in America Survey. J Psychosom Res 2004, 56:497-502.
7. Hart R.P., Morin C.M., Best A.M. Neuropsychological performance in elderly insomnia patients. Aging and Cognition 1995, 2:268-278.
8. Reynolds C.F., Buysse D.J., Kupfer D.J. Treating insomnia in older adults: taking a long-term view. J Am Med Assoc 1999, 281:1034-1035.
9. Roth T., Ancoli-Israel S. Daytime consequences and correlates of insomnia in the United States: results of the 1991 National Sleep Foundation Survey. II. Sleep 1999, 22(Suppl. 2):S354-S358.
10. Sanofi-Synthelabo. Ambien® (zolpidem tartrate) complete prescribing information. 2002.
11. Sanofi-Synthelabo. Ambien CR® (zolpidem tartrate extended-release) complete prescribing information. 2007.
12. Sepracor, Inc. Lunesta® (eszopiclone) complete prescribing information. 2004.
13. Basu R., Dodge H., Stoehr G.P., et al. Sedative-hypnotic use of diphenhydramine in a rural, older adult, community-based cohort: effects on cognition. Am J Geriatr Psychiatry 2003, 11:205-213.
14. Scharf M., Rogowski R., Hull S., et al. Efficacy and safety of doxepin 1, 3 and 6mg in elderly patients with primary insomnia. J Clin Psych 2008, 69:1557-1564.
15. Krystal A., Durrence H., Scharf M., et al. Long-term Efficacy and safety of doxepin 1mg and 3mg in a 12-week sleep laboratory and outpatient trial of elderly subjects with chronic primary insomnia. Sleep 2010, 33:1553-1561.
16. Krystal A., Lankford A., Durrence H., et al. Efficacy and Safety of Doxepin 3 and 6 mg in a 35-day Sleep Laboratory Trial in Adults with Chronic Primary Insomnia. Sleep 2011, 34(10):1433-1442.
17. Roth T., Rogowski R., Hull S., et al. Efficacy and safety of doxepin 1, 3 and 6mg in adults with primary insomnia. Sleep 2007, 30:1555-1561.
18. Roth T., Durrence H., Jochelson P., et al. Efficacy and safety of doxepin 6mg in a model of transient insomnia. Sleep Med 2010, 11:843-847.
19. National Institute of Mental Health: 028 CGI. Clinical Global Impressions. In: Guy, W (ed.), ECDEU Assessment for Psychopharmacology. Rev. Ed. Rockville, Maryland. 1976: 217-222.
20. Morin CM. Insomnia: Psychological Assessment and Management. New York: Guilford Press. 1993.
21. Roth T., Zorick F., Wittig R., et al. The effects of doxepin HCl on sleep and depression. J Clin Psychiatry 1982, 43:366-368.
22. Hajak G., Rodenbeck A., Voderholzer U., et al. Doxepin in the treatment of primary insomnia: a placebo-controlled, double-blind, polysomnographic study. J Clin Psychiatry 2001, 62:453-463.