Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Noctiva for Frequent Urination

FDA news release; 2017 Mar 3

The FDA has approved Noctiva (desmopressin acetate) nasal spray for frequent urination at night in adults due to overproduction of urine.

Indications: Noctiva is a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void.

Dosage/administration: Prime with 5 actuations before initial use if not use for more than 3 days.

  • For patients aged <65 years who are not at increased risk for hyponatremia: Use 1 spray of 1.66 mcg in either nostril nightly approximately 30 minutes before going to bed.
  • For patients ≥65 years or younger patients at risk for hyponatremia: Use 0.83 mcg nightly, which can be increased to one spray of 1.66 mcg after at least 7 days, if needed, provided the serum sodium has remained normal.

Adverse reactions: Common adverse reactions in clinical trials (incidence >2%) included nasal discomfort, nasopharyngitis, nasal congestion, sneezing, hypertension/blood pressure increased, back pain, epistaxis, bronchitis and dizziness.


US Food and Drug Administration. FDA approves first treatment for frequent urination at night due to overproduction of urine. FDA Web site. March 3, 2017. Accessed March 10, 2017.

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