Many things can keep you from getting a good night's sleep. One of the most common is getting up to pee. If it happens to you regularly, twice per night or more, you may have nocturnal polyuria, a fancy name for making too much urine at night.
The causes can be as simple as drinking too much before bedtime or having any of a number of chronic conditions, including diabetes and congestive heart failure.
“Today’s approval provides adults who overproduce urine at night with the first FDA-approved therapeutic option to help reduce the number of times a night they wake up to urinate,” said Hylton V. Joffe, M.D., in the FDA’s Center for Drug Evaluation and Research.
“It is important to know that Noctiva is not approved for all causes of night-time urination, so patients should discuss their symptoms with their health care provider who can determine the underlying cause of the night-time urination and whether Noctiva is right for them,” Joffe said.
Since nocturia can be caused by a wide variety of conditions, doctors should be sure to evaluate each patient and treat the underlying conditions that are contributing to the problem, the FDA cautioned.
Doctors should also confirm overproduction of urine at night with a 24-hour urine collection, if one has not been obtained previously.
Noctiva is being approved with a boxed warning and a Medication Guide because it can cause low sodium levels in the blood (hyponatremia). Severe hyponatremia can be life-threatening if it is not promptly diagnosed and treated, leading to seizures, coma, respiratory arrest, or death.
Noctiva’s effectiveness was demonstrated in two 12-week, randomized, placebo-controlled trials using 1,045 patients 50 years of age and older.
Although these trials showed a small reduction in the average number of night-time urinations with Noctiva compared to placebo, more patients treated with Noctiva were able to at least halve their number of night-time urinations, and patients treated with Noctiva had more nights with one or fewer night-time urinations.
Editor's note: You should not make any decisions solely on the basis of this or any other news story, advertisement, or social media posting. Only your physician can advise you.