Important Administration and Priming Instructions

• Only administer NOCTIVA intranasally. Do not shake the bottle.
• Prime NOCTIVA before using for the first time by pumping 5 actuations into the air away from the face.
• Re-prime by pumping 2 actuations into the air if the product has not been used for more than 3 days.
• If a dose is missed, do not double the dose at next use.
• Two sprays of NOCTIVA 0.83 mcg are not interchangeable with 1 spray of NOCTIVA 1.66 mcg. Prescribe the NOCTIVA nasal spray 1.66 mcg/0.1 mL bottle for patients who are or will be taking the 1.66 mcg dose.

Recommended Dosage

• For patients younger than 65 years of age who are not at increased risk for hyponatremia:
  • The recommended dose is 1 spray of NOCTIVA 1.66 mcg in either the left or right nostril approximately 30 minutes before going to bed.

• For patients ≥65 years of age, or younger patients at increased risk for hyponatremia:
  • The recommended starting dose is 1 spray of NOCTIVA 0.83 mcg in either the left or right nostril approximately 30 minutes before going to bed.
  • After at least 7 days of treatment, the dose can be increased to 1.66 mcg, if needed, provided the serum sodium is within the normal range during treatment with the 0.83 mcg dose.
  • The 0.83 mcg dose did not meet all prespecified efficacy endpoints in clinical trials but may have a lower risk of hyponatremia [see Adverse Reactions (6.1) and Clinical Studies (14)].

Monitoring of Serum Sodium Concentration

Check serum sodium concentrations:

• Prior to initiating or resuming NOCTIVA or increasing the dose. NOCTIVA is contraindicated in patients with hyponatremia or a history of hyponatremia [see Contraindications (4)].
• Within 7 days and approximately 1 month after initiating therapy or increasing the dose.
• Periodically during NOCTIVA therapy, as clinically appropriate. More frequent serum sodium monitoring is recommended for patients 65 years and older and for those at increased risk of hyponatremia.

If the patient develops hyponatremia, NOCTIVA 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)].