"As needed" pharmacotherapy combined with stimulus control treatment in chronic insomnia--assessment of a novel intervention strategy in a primary care setting.

Discontinuous, nonnightly hypnotic therapy in the treatment of chronic insomnia is likely to offer benefits such as maintained efficacy while preventing unnecessary long-term nightly use associated with the risk of tolerance and dependence. Based on the favorable results seen in four zolpidem studies using increasing degrees of flexibility in drug intake schedule, we developed the concept further and investigated "as needed" zolpidem pharmacotherapy amended by the optional use of stimulus control in conditions close to the "real life" practice. In a prospective, observational open study in 550 primary care settings throughout Germany, 2690 patients with chronic insomnia (mean age 59 years, 66% female, 50% with pharmacotherapy pretreatment) were treated with zolpidem according to an "as-needed" (pro re nata) administration treatment schedule (up to five tablets per week, intake nights chosen by the patient), amended by the optional use of behavioral therapy (stimulus control) during drug-free nights. After the three weeks' treatment period, in two thirds of patients (63%) the weekly number of tablets used was reduced in contrast to baseline. The average zolpidem tablet number taken decreased by 28% (from 3.7 to 2.6 per week; p < 0.00001) without any significant impact on the treatment efficacy assessed through the CGI. The subjective latency to sleep onset was reduced from a mean of 74 27 min (p < 0.00001) and total sleep time increased from 5.0 to 6.8 h (p < 0.00001). Efficacy of treatment was rated as very good or good in 93% by the investigators. Adverse events were observed only in 1.2% of patients and were generally of mild nature. No serious adverse event occurred. These results underline the validity of the zolpidem "as needed" treatment concept. It is feasible in a safe and effective manner also in a primary care setting and can be amended by stimulus control. Further research is warranted on the contributions of both treatment components to effectiveness and on the efficacy and safety issues of long-term use.