Short and Long Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing HD

Drug Therapy

Drug Therapy for Insomnia

For many people in the general population, patients use sleeping pills to treat insomnia. However, the risks and benefits of different sleeping pills are different. For some sleeping pills, patients will need a doctor’s prescription and ongoing supervision. Some patients may experience side effects. It is important that we continue to research how effective sleeping pills are at helping people on dialysis with insomnia.

How do sleeping pills work?

The cause of sleeplessness or insomnia is multi-factorial. It can be a consequence of underlying diseases, stress, as well as many other things. One possible mechanism involves neurotransmitters, chemicals that are needed for our brains to function normally such as serotonin and histamine, being out of balance. They also impact how we sleep, eat, think and deal with pain, among other things. Drugs, such as trazodone, restore this chemical balance in the brain, and thus are used to treat insomnia, depression, anxiety disorders, and alcohol/opiate dependence.

Sleep pills in the SLEEP-HD trial

Trazodone is one of a group of drugs called serotonin antagonist and reuptake inhibitors (SARIs). Trazodone is the most common or second most common drug prescribed for insomnia in the United States, including for hemodialysis patients. It is also inexpensive, and available in generic form. The recommended dose is 50 or 100 milligrams by mouth once daily, taken in the evening after meals.

In the SLEEP-HD trial, some patients participating in the treatment phase will be randomly assigned to receive Trazodone, and some will be randomly chosen to receive placebo. To reduce the risks of side effects, the medication will be started at a low dose (50 milligrams). Patients will complete daily sleep diaries and weekly surveys to assess their medical condition and response to Trazodone. These surveys and the sleep diary will help measure changes in the patient’s sleeping patterns, identify any risk of developing side effects, and inform the decision to increase the dose of Trazodone. After the first week of treatment, the dose can be increased to 100 milligrams in order for the desired response to be achieved.

At the end of 6 weeks, if there is significant improvement in patients’ insomnia, both patient and doctor may choose to continue drug therapy outside the study. If the patient decides not to continue treatment with the drug or is not sleeping better with the drug, we will reduce the Trazadone dose over a few weeks until it is stopped completely. We will communicate with patients’ regular doctors during this time to smoothly transition the patients back to their regular care.