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A Randomized Controlled Trial

Charles M. Morin, PhD; Annie Vallières, PhD; Bernard Guay, MD; Hans Ivers, PhD; Josée Savard, PhD; Chantal Mérette, PhD; Célyne Bastien, PhD; Lucie Baillargeon, MD

JAMA. 2009;301(19):2005-2015.

Context  Cognitive behavioral therapy (CBT) and hypnotic medications are efficacious for short-term treatment of insomnia, but few patients achieve complete remission with any single treatment. It is unclear whether combined or maintenance therapies would enhance outcome.

Objectives  To evaluate the added value of medication over CBT alone for acute treatment of insomnia and the effects of maintenance therapies on long-term outcome.

Design, Setting, and Patients  Prospective, randomized controlled trial involving 2-stage therapy for 160 adults with persistent insomnia treated at a university hospital sleep center in Canada between January 2002 and April 2005.

Interventions  Participants received CBT alone or CBT plus 10 mg/d (taken at bedtime) of zolpidem for an initial 6-week therapy, followed by extended 6-month therapy. Patients initially treated with CBT attended monthly maintenance CBT for 6 months or received no additional treatment and those initially treated with combined therapy (CBT plus 10 mg/d of zolpidem) continued with CBT plus intermittent use of zolpidem or CBT only.

Main Outcome Measures  Sleep onset latency, time awake after sleep onset, total sleep time, and sleep efficiency derived from daily diaries (primary outcomes); treatment response and remission rates derived from the Insomnia Severity Index (secondary outcomes).

Results  Cognitive behavioral therapy used singly or in combination with zolpidem produced significant improvements in sleep latency, time awake after sleep onset, and sleep efficiency during initial therapy (all P<.001); a larger increase of sleep time was obtained with the combined approach (P = .04). Both CBT alone and CBT plus zolpidem produced similar rates of treatment responders (60% [45/75] vs 61% [45/74], respectively; P = .84) and treatment remissions (39% [29/75] vs 44% [33/74], respectively; P = .52) with the 6-week acute treatment, but combined therapy produced a higher remission rate compared with CBT alone during the 6-month extended therapy phase and the 6-month follow-up period (56% [43/74 and 32/59] vs 43% [34/75 and 28/68]; P = .05). The best long-term outcome was obtained with patients treated with combined therapy initially, followed by CBT alone, as evidenced by higher remission rates at the 6-month follow-up compared with patients who continued to take zolpidem during extended therapy (68% [20/30] vs 42% [12/29]; P = .04).

Conclusion  In patients with persistent insomnia, the addition of medication to CBT produced added benefits during acute therapy, but long-term outcome was optimized when medication is discontinued during maintenance CBT.

Trial Registration  clinicaltrials.gov Identifier: NCT00042146

Author Affiliations: École de Psychologie (Drs Morin, Vallières, Ivers, Savard, and Bastien), Centre de Recherche Université Laval/Robert-Giffard (Drs Morin, Vallières, Guay, Mérette, and Bastien), and Département de Médecine Familiale (Dr Baillargeon), Université Laval, Québec, Québec, Canada; Institut Universitaire en Santé Mentale de Québec, Québec, Canada (Dr Guay); Centre de Recherche en Cancérologie, Hôpital Hôtel-Dieu de Québec, Québec, Canada (Dr Savard); and Unité de Médecine Familiale, Pavillon CHUL, Québec, Québec, Canada (Dr Baillargeon).

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