NOCDURNA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NOCDURNA (NOCDURNA).
NOCDURNA (desmopressin) is a synthetic analog of vasopressin, an antidiuretic hormone. It acts on V2 receptors in the renal collecting ducts to increase water reabsorption, reducing urine production.
| Metabolism | Primarily metabolized by reduction of the disulfide bond in the liver and kidney. Minor metabolism via peptidolysis. Not a substrate for CYP450 enzymes. |
| Excretion | Renal: >80% as unchanged drug; fecal: ~10% |
| Half-life | ~2.8 hours; short half-life suitable for nocturnal dosing with minimal morning carryover |
| Protein binding | 1% (primarily to albumin) |
| Volume of Distribution | 0.2–0.4 L/kg; limited extravascular distribution consistent with small volume |
| Bioavailability | Oral: ~5% (low due to extensive first-pass metabolism) |
| Onset of Action | Oral: 30 minutes; peak antidiuretic effect at 1 hour |
| Duration of Action | ~8 hours; covers typical sleep period, reducing nocturia episodes |
50 mcg sublingual tablet once daily, 1 hour before bedtime.
| Dosage form | TABLET |
| Renal impairment | eGFR 30-89 mL/min: No adjustment. eGFR <30 mL/min: Not recommended due to lack of data. |
| Liver impairment | No dosage adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B). Not studied in severe impairment (Child-Pugh C). |
| Pediatric use | Not approved for use in pediatric patients under 18 years. Safety and efficacy not established. |
| Geriatric use | No dose adjustment required; plasma concentrations may be higher due to age-related decline in renal function; monitor for hyponatremia. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NOCDURNA (NOCDURNA).
| Breastfeeding | Desmopressin is excreted in human breast milk in very low amounts (M/P ratio approximately 0.3). No adverse effects in nursing infants have been reported. Caution advised; monitor infant for signs of water retention or hyponatremia. |
| Teratogenic Risk | No adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted with desmopressin. Risk cannot be ruled out. Use only if clearly needed. Desmopressin does not cross the placenta in significant amounts; however, potential for uterotonic effects and water intoxication exists. |
■ FDA Black Box Warning
WARNING: HYPONATREMIA. NOCDURNA can cause hyponatremia, which may be life-threatening. Measure serum sodium within 7 days and 1 month after initiation, and periodically thereafter. The elderly and patients with low serum sodium levels or at risk for hyponatremia are at increased risk.
| Serious Effects |
["Hyponatremia or history of hyponatremia","Moderate to severe renal impairment (eGFR <50 mL/min)","Known hypersensitivity to desmopressin or any ingredient","Habitual or psychogenic polydipsia (urine output >40 mL/kg/24h)"]
| Precautions | ["Hyponatremia: Monitor serum sodium in patients at risk; elderly patients, those with low sodium levels, or conditions increasing hyponatremia risk","Fluid retention: Caution in patients with conditions predisposing to fluid overload","Renal impairment: Avoid use in patients with moderate to severe renal impairment (eGFR <50 mL/min)","Cardiovascular disease: Use with caution due to risk of fluid retention and hypertension"] |
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| Fetal Monitoring |
| Monitor maternal vital signs, fluid intake, urinary output, and serum sodium levels. Assess for signs of water intoxication (headache, nausea, vomiting, hyponatremia). Fetal monitoring as appropriate for gestational age; assess amniotic fluid volume if oligohydramnios risk. |
| Fertility Effects | No evidence of impaired fertility in animal studies. In humans, desmopressin does not affect reproductive function or fertility. |