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Noctiva FDA Approval History

Last updated by Judith Stewart, BPharm on March 2, 2021.

FDA Approved: Yes (First approved March 3, 2017)
Brand name: Noctiva
Generic name: desmopressin acetate
Dosage form: Nasal Spray
Company: Serenity Pharmaceuticals, LLC
Treatment for: Nocturia

Noctiva (desmopressin acetate) is vasopressin analog nasal spray indicated for the treatment of nocturia due to nocturnal polyuria.

Noctiva is for use in adults who awaken two or more times per night to urinate. FDA approval of Noctiva was based on two randomized, placebo-controlled studies in 1,045 patients at least 50 years of age with a history of nocturia. In both studies, patients treated with Noctiva showed a small reduction in the average number of night-time urinations compared to patients receiving the placebo, however, more patients treated with Noctiva were able to at least halve their number of night-time urinations, and had more nights with one or fewer night-time urinations.

Noctiva is a nasal spray administered as a single spray into either nostril once daily at night, about 30 minutes before going to bed. It works by temporarily decreasing urine production. Noctiva comes with a boxed warning to alert health care professionals and patients of the risk of hyponatremia, which may be life-threatening if severe. Common side effects include nasal discomfort, nasopharyngitis, nasal congestion, sneezing, hypertension or increased blood pressure, back pain, nose bleeds, bronchitis and dizziness.

Development timeline for Noctiva

Mar  3, 2017Approval FDA Approves Noctiva (desmopressin acetate) Nasal Spray for Nocturia in Adults

Further information

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