For the millions of Americans who have interrupted sleep because of frequent trips to the bathroom, a new drug may provide some relief.
The U.S. Food and Drug Administration recently approved Noctiva (desmopressin acetate) - the first treatment for the condition nocturnal polyuria - the overproduction of urine during the night. Although making a bathroom break at night may not seem on the front lines of medical concerns, roughly 80 - 90% of octogenarians report it as a problem. The disrupted sleep has downstream effects - an increase in daytime sleepiness, depressive symptoms, cognitive dysfunction, and a general decrease in the quality of life.
There are two broad reasons why people end up needing to use the bathroom at night. First, their bladder may not empty properly. In men, this is often due to an enlarging prostate obstructing flow from the bladder; for women, the bladder may be overly sensitive, or the muscles maintaining the bladder's position in the pelvis too lax. Second, the body can make too much urine at night, frequently because of chronic kidney or heart problems.
Noctiva works on the latter of the two reasons, tricking the body into making less urine by increasing the absorption of water through the kidneys. It is taken as a nasal spray, can be used daily and is sprayed roughly 30 minutes before going to sleep.
Noctiva is not for everyone who needs to use the bathroom at night. It is restricted to adults who wake up at least two times per night to urinate. It is not, however, recommended for children - many of whom wet the bed - which is very different than nocturnal polyuria. Also, pregnant women should not consider using Noctiva. Their months of using the bathroom at night are because a baby is sitting on their bladder - not due to overproduction of urine.
People with congestive heart failure or uncontrolled hypertension should not use Noctiva as fluid retention can worsen these underlying conditions. Lastly, because it is a nasal spray, people who have colds or allergies should not use it until their nasal condition has subsided.
The drug was approved by the FDA based on the data from two 12-week, randomized, placebo-controlled trials in 1,045 patients 50 years of age and older with nocturnal polyuria.
The most common side effects of Noctiva in clinical trials included nasal discomfort, cold symptoms (nasopharyngitis), nasal congestion, sneezing, high or increased blood pressure, back pain, nose bleeds, bronchitis and dizziness - all of which may be risks people are willing to take for a good night's sleep.