Nocturia matters

Nearly 50 million people wake up 2 or more times a night to urinate, and the impact goes far beyond lost sleep.1,2

We Surveyed Over 2000 Americans to Measure the Impact of Nocturia. We Found3:
65 %

of nocturia sufferers have never heard of their condition.

67 %

are not aware that nocturia is a diagnosable medical condition.

In 80% of cases, nocturia is caused by nocturnal polyuria4

Nocturnal polyuria occurs when the kidneys overproduce urine at night due to reduced vasopressin secretion, a naturally occurring antidiuretic hormone that concentrates urine and reduces urinary output.5

Overactive bladder (OAB) and benign prostatic hyperplasia (BPH) medications don’t target nocturnal polyuria6

Treating in the bladder or prostate may not address the issue because both treat downstream of the real problem.6

That means 8 in 10 patients with nocturia in your practice are likely still waking up tonight to urinate, even if their daytime OAB/BPH symptoms are under control.4

Nocturia impacts sleep, which can lead to negative effects on everyday life5,7,8

Sleep disturbances due to nocturia have been shown to impair functioning, quality of life, overall health, and productivity. It can lead to problems like5,8-10:

Grogginess

Loss of productivity

Falls + fractures

Depression

Cardiovascular disease

Obesity

While many patients wake up 4+ times a night due to nocturia, bother begins much earlier. In fact, 71% of patients who wake up just 2 times a night are bothered by their nocturia.11
Evelyn is just one of those patients. Watch her story.

Take action

Many of your patients could be waking up tonight because of nocturia due to nocturnal polyuria. With NOCTIVA, you could reduce its impact.1

Take action

Many of your patients could be waking up tonight because of nocturia due to nocturnal polyuria. With NOCTIVA, you could reduce its impact.1

Next up

See how NOCTIVA impacted patients in 2 clinical trials.12

Efficacy Data
REFERENCES

1. Fitzgerald MP, Litman HJ, Link CL, McKinlay JB; BACH Survey Investigators. The association of nocturia with cardiac disease, diabetes, body mass index, age and diuretic use: results from the BACH survey. J Urol. 2007;177(4):1385-1389. 2. Population distribution by age. Kaiser Family Foundation website. https://www.kff.org/other/state-indicator/distribution-by-age. Accessed December 16, 2017. 3. Data on file. Avadel Specialty Pharmaceuticals, LLC. 4. Weiss JP, van Kerrebroeck PE, Klein BM, Nørgaard JP. Excessive nocturnal urine production is a major contributing factor to the etiology of nocturia. J Urol. 2011;186(4):1358-1363. 5. Ancoli-Israel S, Bliwise DL, Nørgaard JP. The effect of nocturia on sleep. Sleep Med Rev. 2011;15(2):91-97. 6. Weiss JP. Nocturia: focus on etiology and consequences. Rev Urol. 2012;14(3-4):48-55. 7. Ohayon MM. Nocturnal awakenings and comorbid disorders in the American general population. J Psychiatr Res. 2008;43(1):48-54. 8. Stanley N. The underestimated impact of nocturia on quality of life. Eur Urol. 2005;4(7)(suppl):17-19. 9. Kupelian V, Wei JT, O’Leary MP, Nørgaard JP, Rosen RC, McKinlay JB. Nocturia and quality of life: results from the Boston Area Community Health Survey. Eur Urol. 2012;61(1):78-84. 10. Cappuccio FP, Cooper D, D’Elia L, Strazullo P, Miller MA. Sleep duration predicts cardiovascular outcomes: a systematic review and meta-analysis of prospective studies. Eur Heart J. 2011;32(12):1484-1492. 11. Tikkinen KA, Johnson TM, Tammella TL, et al. Nocturia frequency, bother, and quality of life: How often is too often? A population-based study in Finland. Eur Urol. 2010;57(3):488-496. 12. NOCTIVA [package insert]. Chesterfield, MO: Avadel Specialty Pharmaceuticals, LLC; 2017.

Order Samples
INDICATION AND IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

WARNING: HYPONATREMIA

See full prescribing information for complete boxed warning.

  • NOCTIVA can cause hyponatremia, which may be life-threatening if severe.
  • NOCTIVA is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids.
  • Ensure serum sodium is normal before starting or resuming NOCTIVA. Measure serum sodium within seven days and approximately one month after initiating therapy or increasing the dose, and periodically during treatment. More frequently monitor serum sodium in patients 65 years of age and older and in patients at increased risk of hyponatremia.
  • If hyponatremia occurs, NOCTIVA may need to be temporarily or permanently discontinued.
Indications and usage

NOCTIVA is a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void.

Limitation of Use: Not studied in patients younger than 50 years of age.

Contraindications
  • Hyponatremia or a history of hyponatremia
  • Polydipsia
  • Primary nocturnal enuresis
  • Concomitant use with loop diuretics or systemic or inhaled glucocorticoids
  • Estimated glomerular filtration rate below 50 mL/min/1.73 m2
  • Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
  • During illnesses that can cause fluid or electrolyte imbalance
  • New York Heart Association (NYHA) Class II-IV congestive heart failure
  • Uncontrolled hypertension
Warnings and Precautions
  • Fluid retention: Not recommended in patients at risk of increased intracranial pressure or history of urinary retention. Monitor volume status in patients with NYHA Class I congestive heart failure.
  • Nasal conditions: Discontinue in patients with concurrent nasal conditions that may increase absorption, until resolved.
Adverse Reactions

Common adverse reactions in clinical trials (incidence >2%) included nasal discomfort, nasopharyngitis, nasal congestion, sneezing, hypertension / blood pressure increased, back pain, epistaxis, bronchitis and dizziness.

Drug Interactions

Monitor serum sodium more frequently when NOCTIVA is concomitantly used with drugs that may cause water retention and increase the risk for hyponatremia (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, nonsteroidal anti-inflammatories, lamotrigine and carbamazepine).

Use in Specific Populations
  • Pregnancy: Use of NOCTIVA is not recommended.
  • Pediatric: Do not use NOCTIVA for primary nocturnal enuresis in children.

To report SUSPECTED ADVERSE REACTIONS, contact Avadel at 1-877-638-4579 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

INDICATION AND IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

WARNING: HYPONATREMIA

See full prescribing information for complete boxed warning.

  • NOCTIVA can cause hyponatremia, which may be life-threatening if severe.
  • NOCTIVA is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids.
  • Ensure serum sodium is normal before starting or resuming NOCTIVA. Measure serum sodium within seven days and approximately one month after initiating therapy or increasing the dose, and periodically during treatment. More frequently monitor serum sodium in patients 65 years of age and older and in patients at increased risk of hyponatremia.
  • If hyponatremia occurs, NOCTIVA may need to be temporarily or permanently discontinued.
Indications and usage

NOCTIVA is a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void.

Limitation of Use: Not studied in patients younger than 50 years of age.

Contraindications
  • Hyponatremia or a history of hyponatremia
  • Polydipsia
  • Primary nocturnal enuresis
  • Concomitant use with loop diuretics or systemic or inhaled glucocorticoids
  • Estimated glomerular filtration rate below 50 mL/min/1.73 m2
  • Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
  • During illnesses that can cause fluid or electrolyte imbalance
  • New York Heart Association (NYHA) Class II-IV congestive heart failure
  • Uncontrolled hypertension
Warnings and Precautions
  • Fluid retention: Not recommended in patients at risk of increased intracranial pressure or history of urinary retention. Monitor volume status in patients with NYHA Class I congestive heart failure.
  • Nasal conditions: Discontinue in patients with concurrent nasal conditions that may increase absorption, until resolved.
Adverse Reactions

Common adverse reactions in clinical trials (incidence >2%) included nasal discomfort, nasopharyngitis, nasal congestion, sneezing, hypertension / blood pressure increased, back pain, epistaxis, bronchitis and dizziness.

Drug Interactions

Monitor serum sodium more frequently when NOCTIVA is concomitantly used with drugs that may cause water retention and increase the risk for hyponatremia (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, nonsteroidal anti-inflammatories, lamotrigine and carbamazepine).

Use in Specific Populations
  • Pregnancy: Use of NOCTIVA is not recommended.
  • Pediatric: Do not use NOCTIVA for primary nocturnal enuresis in children.

To report SUSPECTED ADVERSE REACTIONS, contact Avadel at 1-877-638-4579 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.