Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You or Your Team.

Learn More →

“As Needed” Pharmacotherapy Combined with Stimulus Control Treatment in Chronic Insomnia—Assessment of a Novel Intervention Strategy in a Primary Care Setting

“As Needed” Pharmacotherapy Combined with Stimulus Control Treatment in Chronic... Discontinuous, nonnightly hypnotic therapy in the treatment of chronic insomnia is likely to offer benefits such as maintained efficacy while preventing unnecessary long-term nightly use associated with the risk of tolerance and dependence. Based on the favorable results seen in four zolpidem studies using increasing degrees of flexibility in drug intake schedule, we developed the concept further and investigated “as needed” zolpidem pharmacotherapy amended by the optional use of stimulus control in conditions close to the “real life” practice. In a prospective, observational open study in 550 primary care settings throughout Germany, 2690 patients with chronic insomnia (mean age 59 years, 66% female, 50% with pharmacotherapy pretreatment) were treated with zolpidem according to an “as-needed” (pro re nata) administration treatment schedule (up to five tablets per week, intake nights chosen by the patient), amended by the optional use of behavioral therapy (stimulus control) during drug-free nights. After the three weeks' treatment period, in two thirds of patients (63%) the weekly number of tablets used was reduced in contrast to baseline. The average zolpidem tablet number taken decreased by 28% (from 3.7 to 2.6 per week; p < 0.00001) without any significant impact on the treatment efficacy assessed through the CGI. The subjective latency to sleep onset was reduced from a mean of 74 27 min (p < 0.00001) and total sleep time increased from 5.0 to 6.8 h (p < 0.00001). Efficacy of treatment was rated as very good or good in 93% by the investigators. Adverse events were observed only in 1.2% of patients and were generally of mild nature. No serious adverse event occurred. These results underline the validity of the zolpidem “as needed” treatment concept. It is feasible in a safe and effective manner also in a primary care setting and can be amended by stimulus control. Further research is warranted on the contributions of both treatment components to effectiveness and on the efficacy and safety issues of long-term use. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Annals of Clinical Psychiatry Springer Journals

“As Needed” Pharmacotherapy Combined with Stimulus Control Treatment in Chronic Insomnia—Assessment of a Novel Intervention Strategy in a Primary Care Setting

Download PDF
7 pages

Loading next page...
 
/lp/springer-journals/as-needed-pharmacotherapy-combined-with-stimulus-control-treatment-in-MhhxHRi0cO
Publisher
Springer Journals
Copyright
Copyright © 2002 by American Academy of Clinical Psychiatrists
Subject
Medicine & Public Health; Neurology; Psychiatry; Psychopharmacology
ISSN
1040-1237
eISSN
1573-3238
DOI
10.1023/A:1015274625699
Publisher site
See Article on Publisher Site

Abstract

Discontinuous, nonnightly hypnotic therapy in the treatment of chronic insomnia is likely to offer benefits such as maintained efficacy while preventing unnecessary long-term nightly use associated with the risk of tolerance and dependence. Based on the favorable results seen in four zolpidem studies using increasing degrees of flexibility in drug intake schedule, we developed the concept further and investigated “as needed” zolpidem pharmacotherapy amended by the optional use of stimulus control in conditions close to the “real life” practice. In a prospective, observational open study in 550 primary care settings throughout Germany, 2690 patients with chronic insomnia (mean age 59 years, 66% female, 50% with pharmacotherapy pretreatment) were treated with zolpidem according to an “as-needed” (pro re nata) administration treatment schedule (up to five tablets per week, intake nights chosen by the patient), amended by the optional use of behavioral therapy (stimulus control) during drug-free nights. After the three weeks' treatment period, in two thirds of patients (63%) the weekly number of tablets used was reduced in contrast to baseline. The average zolpidem tablet number taken decreased by 28% (from 3.7 to 2.6 per week; p < 0.00001) without any significant impact on the treatment efficacy assessed through the CGI. The subjective latency to sleep onset was reduced from a mean of 74 27 min (p < 0.00001) and total sleep time increased from 5.0 to 6.8 h (p < 0.00001). Efficacy of treatment was rated as very good or good in 93% by the investigators. Adverse events were observed only in 1.2% of patients and were generally of mild nature. No serious adverse event occurred. These results underline the validity of the zolpidem “as needed” treatment concept. It is feasible in a safe and effective manner also in a primary care setting and can be amended by stimulus control. Further research is warranted on the contributions of both treatment components to effectiveness and on the efficacy and safety issues of long-term use.

Journal

Annals of Clinical Psychiatry – Springer Journals

Published: Oct 10, 2004

References

  • Prevalence and persistence of sleep complaints in a rural older community sample: The MoVIES project
    Ganguli, M; Reynolds, CF; Gilby, JE
  • Prevalence and treatment of insomnia in general practice. A longitudinal study
    Hohagen, F; Rink, K; Kappler, C; Schramm, E; Riemann, D; Weyerer, S; Berger, M
  • NISAS-2000. Nationwide Insomnia Screening and Awareness Study
    Wittchen, HU; Krause, P; Höfler, M; Pittrow, D; Winter, S; Spiegel, B; Hajak, G; Riemann, D; Steiger, H; Pfister, H
  • Chronic sleep complaints. Results of a representative survey in Germany
    Simen, S; Hajak, G; Schlaf, G; Westenhöfer, J; Rodenbeck, A; Bandelow, B; Pudel, V; Rüther, E
  • Clinical correlates of insomnia in patients with chronic illness
    Katz, DA; McHorney, CA
  • Form, frequency, and burden of sleep problems in general health care
    Ñstün, T; Privett, M; LeCrubier, Y; Weiller, E; Simon, G; Korten, A; Bassett, S; Maier, W; Sartorius, N
  • Sleep onset insomnia, sleep maintaining insomnia and insomnia with early morning awakening-temporal stability of subtypes in a longitudinal study on general practice attenders
    Hohagen, F; Kappler, C; Schramm, E; Riemann, D; Weyerer, S; Berger, M
  • Task force on sedative hypnotics: A Report
  • The treatment of sleep disorders of older people
  • Drugs and insomnia: The use of medications to promote sleep
  • Recommendations for the diagnosis and therapy of insomnia
    Clarenbach, P; Steinberg, R; Weeß, HG; Berger, M
  • Impact of neuro-pharmacology in the 1990s-Treatment strategies for anxiety disorders and insomnia
  • Consensus for the pharmacologic management of insomnia in the new millenium
    Roth, T; Hajak, G; Ñstün, B
  • Zolpidem: An update of its pharmacology, therapeutic efficacy and tolerability in the treatment of insomnia
    Holm, KJ; Goa, KL
  • Clinical pharmacokinetics and pharmacodynamics of zolpidem
    Salva, P; Costa, J
  • Zolpidem: An Update of its Pharmacological Properties and Therapeutic Place in the Management of Insomnia
    Kryger, M; Salva, P
  • Zolpidem: An Update of its Pharmacological Properties and Therapeutic Place in the Management of Insomnia
    Vogel, G; Poirrier, R
  • Tolerance and rebound insomnia with rapidly eliminated hypnotics: A metaanalysis of sleep laboratory studies
    Soldatos, CR; Dikeos, DG; Whitehead, A
  • Comparison of continuous versus intermittent administration of zolpidem in chronic insomniacs:Adouble-blind, randomised pilot study
    Cluydts, R; Peeters, K; De Bouyalsky, I; Lavoisy, J
  • Efficacy and safety of zolpidem 10 mg administered pro re nata (P.R.N.) during4 weeks in patients with chronic insomnia
    Arbus, L; Lavoisy, J; Belin, J; Soubrane, C
  • Eight weeks of non-nightly use of zolpidem for primary insomnia
    Walsh, JK; Roth, T; Randazzo, A; Erman, M; Jamieson, A; Scharf, M; Schweitzer, PK; Ware, JC
  • Continuous versus non-nightly use of zolpidem in chronic insomnia: Results of a large-scale, doubleblind, randomized, outpatient study
    Hajak, G; Cluydts, R; Declerck, A; Estivill, SE; Middleton, A; Sonka, K; Unden, M
  • Diagnostic and Statistical Manual of Mental Disorders
  • Clinical descriptions and guidelines
  • Case Studies in Insomnia
    Bootzin, RR; Epstein, D; Wood, JM
  • The Pittsburgh Sleep Quality Index: A new instrument for psychiatric practice and research
    Buysse, DJ; Reynolds, CF; Monk, TH; Berman, SR; Kupfer, DJ
  • Multifactor behavioral treatment of chronic sleep-onset insomnia using stimulus control and the relaxation response
    Jacobs, GD; Rosenberg, PA; Friedman, R; Matheson, J; Peavy, GM; Domar, AD; Benson, H
  • The treatment of sleep-maintenance insomnia with stimulus-control techniques
    Lacks, P; Bertelson, AD; Sugerman, J; Kunkel, J
  • Nonpharmacological interventions for insomnia: A meta-analysis of treatment efficacy
    Morin, CM; Culbert, JP; Schwartz, SM.
  • Epidemiological evidence for a low abuse potential of zolpidem
    Soyka, M; Bottlender, R; Möller, HJ
  • Feasibility of an every-other-night regimen in insomniac patients: Subjective hypnotic effectiveness of quazepam, triazolam, and placebo
    Scharf, MB