
NOCDURNA has been studied for years
Proven clinical trial experience
- NOCDURNA has been evaluated in a long-term clinical trial of up to 3 years1
MOST COMMON ADVERSE REACTIONS
Common adverse reactions taken from the safety database 1*
Women | Men | |||
---|---|---|---|---|
Adverse Reaction† | Placebo (N=173) |
NOCDURNA 27.7 mcg (N=196) |
Placebo (N=213) |
NOCDURNA 55.3 mcg (N=195) |
Dry Mouth | 19 (11%) | 23 (12%) | 27 (13%) | 27 (14%) |
Hyponatremia or blood sodium decreased | 3 (2%) | 6 (3%) | 1 (<1%) | 8 (4%) |
Headache | 5 (3%) | 4 (2%) | 3 (1%) | 7 (4%) |
Dizziness | 0 | 3 (2%) | 1 (<1%) | 5 (3%) |
Women | ||
---|---|---|
Adverse Reaction* | Placebo (N=173) |
NOCDURNA 27.7 mcg (N=196) |
Dry Mouth | 19 (11%) | 23 (12%) |
Hyponatremia | 3 (2%) | 6 (3%) |
Headache | 5 (3%) | 4 (2%) |
Dizziness | 0 | 3 (2%) |
Men | ||
---|---|---|
Adverse Reaction* | Placebo (N=213) |
NOCDURNA 55.3 mcg (N=195) |
Dry Mouth | 27 (13%) | 27 (14%) |
Hyponatremia | 1 (<1%) | 8 (4%) |
Headache | 3 (1%) | 7 (4%) |
Dizziness | 1 (<1%) | 5 (3%) |
- Includes Study 1, Study 2, Study 3, and an open-label extension for Study 3, which studied patients for a duration of up to 3 years.
- Includes adverse reactions occurring during up to 3 months of treatment in patients who continued from Study 3 into Study 4.
The most common adverse reactions reported with both the 27.7 mcg/day and 55.3 mcg/day dosages included dry mouth, hyponatremia or blood sodium decrease, headache, and dizziness.1
The high incidence of dry mouth may have been affected by specific query about dry mouth in Study 3. In Studies 1 and 2 where the adverse reaction was spontaneously reported, the incidence was ≤4%.1
Reference: 1. NOCDURNA [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc.