0341 SEQUENTIAL THERAPIES FOR COMORBID AND PRIMARY INSOMNIA: A RANDOMIZED CONTROLLED TRIAL

Despite evidence supporting pharmacological and cognitive/behavioral insomnia therapies, it remains unclear how best to combined these therapies to optimize outcomes. This paper reports findings from a two-site randomized clinical trial examining the efficacy of these therapies, employed individually and in various sequences. Patients were 211 adults (132 women; M age = 45.6 ± 14.9 years old) with insomnia disorder, including 72 who also presented a comorbid psychiatric disorder. They were randomly assigned to first-stage 6-week therapy involving either behavioral therapy (BT) or zolpidem. Patients in remission continued on maintenance therapy for 12 months. Those not achieving remission were randomized to a second, 6-week treatment involving either pharmacotherapy (zolpidem or trazodone) or psychological therapy (BT or cognitive therapy-CT). The primary end points reported here include Insomnia Severity Index - defined treatment response (≥ 8 point decline) and remission (total score < 8). Intent-to-treat analyses showed that there were similar proportions of treatment responders (45% vs. 41%) after initial treatment with BT or zolpidem, but a larger proportion of remitters in BT (33% vs. 25%). For those who did not remit with BT, the addition of zolpidem or cognitive therapy as a second treatment yielded equivalent response rates (54% and 56%, respectively), but larger remission rates when there was a switch of treatment modality (BT to zolpidem; 35%) than when patients remained within the same treatment modality (BT to CT; 22%). For those who did not remit with zolpidem, the addition of BT or trazodone yielded identical response rates (44%) and remission rates (22%). Although response/remission rates were generally lower among patients with psychiatric comorbidity, treatment sequences that involved BT followed by CT or zolpidem followed by trazodone led to better outcomes for comorbid insomnia than for insomnia without comorbidity. These preliminary, descriptive, findings suggest that sequential therapy is an effective strategy to optimize insomnia management. Adding a second treatment produces an added value for those who fail to respond to initial therapies. Patients with comorbid insomnia may benefit from therapies (cognitive therapy, antidepressant) that target mood in addition to sleep. National Institutes of Health (MH091053).

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