Efficacy and safety of doxepin 6 mg in a model of transient insomnia

Sleep Medicine

Volumn 11, Issue 9, 2010, Pages 843-847

  Roth, Thomas ^a   Heith Durrence, H ^b   Jochelson, Philip ^c   Peterson, Gregg ^d   Ludington, Elizabeth ^d   Rogowski, Roberta ^d   Scharf, Martin ^e   Lankford, Alan ^f  

^a HENRY FORD HEALTH SYSTEM   (United States)

^b Ambit Biosciences   (United States)

^c MALLINCKRODT PHARMACEUTICALS   (United States)

^d Somaxon Pharmaceuticals Inc   (United States)

^e Tri State Sleep Disorders Center   (United States)

^f Sleep Disorders Center of Georgia   (United States)

Author keywords

Doxepin; Efficacy and safety; Histamine; Insomnia; Pharmacotherapy; Transient insomnia

Indexed keywords

DOXEPIN; PLACEBO;

ADULT; AROUSAL; ARTICLE; CLINICAL EVALUATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; EVENING DOSAGE; FEMALE; HUMAN; INSOMNIA; MAJOR CLINICAL STUDY; MALE; POLYSOMNOGRAPHY; PRIORITY JOURNAL; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; SLEEP STAGE; SLEEP TIME; UNSPECIFIED SIDE EFFECT;

ADULT; DOUBLE-BLIND METHOD; DOXEPIN; HUMANS; HYPNOTICS AND SEDATIVES; POLYSOMNOGRAPHY; SLEEP; SLEEP INITIATION AND MAINTENANCE DISORDERS; TIME FACTORS;

EID: 79952587747     PISSN: 13899457     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.sleep.2010.07.006     Document Type: Article

References (15)

1. Reite M, Ruddy J, Nagel K. Insomnia complaints. Concise guide to evaluation and management of sleep disorders. 2nd ed. Washington, DC: American Psychiatric Press, Inc.; 1997. p. 47-112.
2. Doghramji P.P. Detection of insomnia in primary care. J Clin Psychiatry 2001, 62(Suppl. 10):18-26.
3. Roehrs T, Zorick FJ, Roth T. Transient and short-term insomnia. In: Kryger MH, Roth T, Dement WC, editors. Principles and practice of sleep medicine. 3rd ed. Philadelphia, PA: Saunders; 2000. p. 624-32.
4. Berman T.M., Nino-Murcia G., Roehrs T. Sleep disorders: take them seriously. Patient Care 1990, 85-112.
5. Nino-Murcia G. Diagnosis and treatment of insomnia and risks associated with lack of treatment. J Clin Psychiatry 1992, 53(Suppl.):43-47.
6. Stepanski E., Roehrs T., Saab P., Zorick F., Roth T. Readaptation to the long-term sleep studies. Bull Psychonomic Soc 1981, 17:224-226.
7. Rechtschaffen A, Kales A, editors. A manual of standardized terminology, techniques and scoring system for sleep stages of human subjects. Los Angeles, CA: UCLA: Brain Information Service/Brain Research Institute; 1968.
8. Roth T., Stubbs C., Walsh J. Ramelteon (TAK-375), a selective MT1/MT2-receptor antagonist, reduces latency to persistent sleep in a model of transient insomnia related to a novel sleep environment. Sleep 2005, 28:303-307.
9. Roth T., Roehrs T., Vogel G. Zolpidem in the treatment of transient insomnia: a double-blind, randomized comparison with placebo. Sleep 1995, 18:246-251.
10. Erman M., Erwin C., Gengo F., et al. Comparative efficacy of zolpidem and temazepam in transient insomnia. Hum Psychopharmacol Clin Exp 2001, 16:169-176.
11. Rosenberg R., Caron J., Roth T., et al. An assessment of the efficacy and safety of eszopiclone in the treatment of transient insomnia in healthy adults. Sleep Med 2005, 6:15-22.
12. Walsh J.K., Schweitzer P.K., Sugerman J.L., et al. Transient insomnia associated with a 3-hour phase advance of sleep time and treatment with zolpidem. J Clin Psychopharmacol 1990, 10:184-189.
13. Roth T., Rogowski R., Hull S., et al. Efficacy and safety of doxepin 1, 3 and 6 mg in adults with primary insomnia. Sleep 2007, 30:1555-1561.
14. Scharf M., Rogowski R., Hull S., et al. Efficacy and safety of doxepin 1, 3 and 6 mg in elderly patients with primary insomnia. J Clin Psych J Clin Psyc 2008, 69:1557-1564.
15. Krystal A, Durrence H, Scharf M, et al. Long-term 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, submitted for publication.