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)
ofzolpidemforaninitial6-weektherapy,followedbyextended6-monththerapy.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
