Cognitive-behavior 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.
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, clinical trial involving two-stage therapy with 160 adults with persistent insomnia treated at a university hospital sleep center between January 2002 and April 2005.
Participants received CBT alone or CBT plus zolpidem for an initial six-week therapy, followed by extended 6-month therapy. Patients treated with CBT initially attended monthly maintenance CBT or no additional treatment and those treated with combined therapy initially continued with CBT plus intermittent medication or CBT without medication (tapering).
Main Outcome Measures
Sleep onset latency, time awake after sleep onset, total sleep time, and sleep efficiency derived from daily diaries (primary) and response and remission rates derived from the Insomnia Severity Index (secondary).
CBT used singly or in combination with medication produced significant improvements of sleep latency, time awake after sleep onset, and sleep efficiency during initial therapy (Ps < 0.001); a larger increase of sleep time was obtained with the combined approach (P = 0.04). Both CBT and combined therapies produced similar rates of treatment responders (60% [45/75] vs. 61% [45/74], P = 0.84) and remissions (39% [29/75] vs. 44% [33/74], P = 0.52) with acute treatment, but combined therapy produced a higher remission rate relative to CBT alone over the extended therapy and follow up period (56% [43/74, 32/59] vs. 43% [34/75, 28/68], P = 0.05). 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 relative to patients who remained on medication during extended therapy (67% [20/30] vs. 41% [12/29], P = 0.04)
In patients with persistent insomnia, the addition of medication to CBT produces added benefits during acute therapy, but long-term outcome is optimized when medication is discontinued during maintenance CBT.