What is the SMART Insomnia Study?
Most patients who have problems falling or staying asleep (insomnia) use over-the-counter or prescription medications to manage this sleep disorder. Surprisingly, little is known about the relative safety and effectiveness of these commonly used approaches. Guidance regarding management of insomnia is urgently needed, especially given that up to 50% of patients in Primary care suffer with insomnia .
With support from Patient-Centered Outcomes Research Institute (PCORI), we are conducting a first of its kind study on precisely this issue. We are conducting a large scale, placebo controlled, randomized clinical trial of the five most commonly used medications for the management of insomnia including melatonin, diphenhydramine ("Benadryl"), zolpidem ("Ambien"), trazodone ("Desyrel"), and doxepin ("Silenor"). All patients will receive medication on a nightly basis along with sleep hygiene education.
Our study is registered at Clinical Trials.gov.
How does this study work?
If you do not experience an improvement in your insomnia at 2 weeks (and you tolerated the initial dose), you will be offered a higher dose. If there is still no improvement after 4 weeks, you will be offered an alternative medication; this will provide you a chance to find a medication that works for you. If one of the treatments results in a treatment response (~50% improvement in one’s insomnia symptoms), you will be followed for an additional 5 months. Medication will be assessed for its safety and effectiveness for a total of 6 months.
At the end of the 6-month trial you will be referred back to your primary care provider with a one month's prescription for the study medication (a “bridge” prescription). You will be asked to schedule an appointment (at your earliest convenience) so that you and your provider can decide on next steps.
Note: We will send a summary of your progress in our study to your provider (and a copy will be available to you as well). These data may inform your joint decision about whether or not to continue therapy.
If no medications were effective for you, you will be offered (at no cost) cognitive behavior therapy for insomnia (CBT-I) delivered by specialists in Behavioral Sleep Medicine.
Participate In Our Study
If you would like to participate in the SMART Insomnia Study, please complete a screening form at Sleepless in Philly.
Once you complete the form, we will reach out to you within two weeks to discuss next steps.
Benefits of Participating
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All FDA approved medications or supplements; no experimental drugs
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Each time a treatment is ineffective, you will have the opportunity to increase the dose and/or switch to a new medication. This increases that chance that you will find a medication that works for you.
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All treatments are provided at no cost to you, including Cognitive Behavior Therapy for Insomnia (CBT-I) if none of the medical treatments work for you.
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Treatment comes with monitoring from experts in sleep medicine
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Supplied Fitbit is yours to keep
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This is a great video about clinical trials and their importance.
