Xeloda and Insomnia

In clinical studies on Xeloda, insomnia was a commonly reported side effect, occurring in up to 8 percent of people. Some of the symptoms of insomnia can include difficulty falling asleep, waking up often during the night and having trouble going back to sleep, and unrefreshing sleep. If you are taking Xeloda and insomnia occurs, there are some things you can try, such as keeping a regular sleep-wake cycle and avoiding alcohol, caffeine, and nicotine in the four to six hours before bedtime.

 

Does Xeloda Cause Insomnia?

Xeloda® (capecitabine) is a prescription medicine used to treat breast cancer and colorectal cancer (which is cancer of either the colon or rectum). As with other medicines, several side effects are possible with Xeloda. Insomnia appears to be one of the more common. This is based on a clinical study where up to 8 percent of people taking the drug reported insomnia as a side effect.
 
People with insomnia have one or more of the following symptoms:
 
  • Difficulty falling asleep
  • Waking up often during the night and having trouble going back to sleep
  • Waking up too early in the morning
  • Unrefreshing sleep.
     
However, it is difficult to tell if insomnia is caused by Xeloda or by other factors (such as the condition itself), due to the way clinical studies of Xeloda were designed. In most non-cancer studies, a portion of the participants takes a placebo (sugar pill). This pill will not treat the condition and causes no side effects. Any side effect that does occur in the placebo group is because of the condition or other factors. By having people take a placebo, it is possible to compare the side effects between the group taking the medicine and those who are not. This allows researchers to see what, if any, impact the medicine has on increasing or decreasing a particular problem.
 
However, because it would be unethical to not treat cancer, there was no placebo group for most Xeloda studies. Therefore, it is difficult to tell if insomnia is due to Xeloda, other factors, or a combination of both.
 
(Xeloda and Insomnia Continued: Page 2)
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;