Nocdurna Dosage

Dosing Recommendations

Before starting or resuming NOCDURNA assess the sodium concentration and only start or resume NOCDURNA in patients with a normal serum sodium concentration [see Warnings and Precautions (5.1), Contraindications (4)].

The recommended NOCDURNA dosage in:

• Women is 27.7 mcg once daily, one hour before bedtime, administered sublingually without water.
• Men is 55.3 mcg once daily, one hour before bedtime, administered sublingually without water.

Keep the tablet under the tongue until it has fully dissolved.

The recommended dose for women is lower than for men because women are more sensitive to the effects of NOCDURNA and had a higher risk of hyponatremia with the 55.3 mcg dose in clinical trials.

Instruct patients to empty their bladder immediately before bedtime. Limit fluid intake to a minimum from 1 hour before until 8 hours after administration [see Warnings and Precautions (5.1) and Patient Counseling Information (17)].

Sodium Monitoring

Ensure serum sodium concentration is normal prior to initiating or resuming NOCDURNA. NOCDURNA is contraindicated in patients with hyponatremia or a history of hyponatremia [see Contraindications (4)].

Check the serum sodium concentration within the first week and again at one month after initiating or resuming therapy.

Periodically monitor serum sodium during NOCDURNA therapy, as clinically appropriate. More frequent serum sodium monitoring is recommended for patients 65 years and older and for those at risk of hyponatremia.

If the patient develops hyponatremia, NOCDURNA may need to be temporarily or permanently discontinued, and treatment for the hyponatremia instituted, depending on the clinical circumstances, including the duration and severity of the hyponatremia [see Warnings and Precautions (5.1)].