0475 Long-Term Medical Treatment of Chronic Insomnia: A Further Exploration of Maintenance Regimens

Abstract Introduction At present the uncodified standard for the medical treatment of insomnia is to use hypnotics as needed or intermittently (3-5x per week). While both approaches are dose sparing, neither may provide for the highest rate of treatment responding. Based on prior work, it was hypothesized that intermittent dosing without the interspersion of placebos would be the least effective strategy. Methods A four group RCT with longitudinal follow-up was used to evaluate a two-step treatment protocol. In Step-1, all patients were treated nightly with zolpidem (5mg or 10mg) for one month. In Step-2, treatment responses were maintained for up to 3 months with one of four strategies: nightly dosing; intermittent dosing; or intermittent dosing w/ placebos interspersed (either 1 or 3 active doses per week). Group differences were evaluated with an omnibus exact test for response rates, a Log-Rank test for time to relapse, and a GEE model was used to assess sleep continuity. Results 115 subjects with chronic insomnia were enrolled in Step-1. 10% of subjects were lost to follow-up. 82 subjects (71%) exhibited treatment responses and were randomized in Step-2 to one of the four maintenance treatment conditions. The positive clinical effects in Step-1 were on sleep latency (reduced by 43%), wake after sleep onset (reduced by 44%), and total sleep time (increased by 8%). Early morning awakening was largely unaffected (reduced by about 3%). In step-2, the four maintenance strategies did not significantly differ with respect to: relapse rates; latency to relapse; or average sleep continuity. As assessed with a weekly medical symptom check list, the groups did not differ with respect to the incidence, frequency, or severity of medical symptoms. Conclusion As expected, Step-1 produced good treatment outcomes. Contrary to expectation, all forms of intermittent dosing used for maintenance therapy were sufficient to maintain treatment response. These results suggest that an optimal strategy for the long-term medical treatment of insomnia is to utilize a two-step regimen: nightly dosing for one month (to maximize treatment responding) and (2) intermittent dosing for maintenance therapy (to reduce the amount of a drug required to maintain therapeutic effects). Support (if any) N/A