Eszopiclone (Page 3 of 9)

Adverse Reactions Observed at an Incidence of ≥2% in Controlled Trials

Table 1 shows the incidence of adverse reactions from a Phase 3 placebo-controlled study of eszopiclone at doses of 2 or 3 mg in nonelderly adults. Treatment duration in this trial was 44 days. The table includes only reactions that occurred in 2% or more of patients treated with eszopiclone 2 mg or 3 mg in which the incidence in patients treated with eszopiclone was greater than the incidence in placebo-treated patients.

Table 1: Incidence (%) of Adverse Reactions in a 6-Week Placebo-Controlled Study in Nonelderly Adults with Eszopiclone 1

Adverse Reaction

Placebo

(n=99)

Eszopiclone 2 mg

(n=104)

Eszopiclone 3 mg

(n=105)

Body as a Whole

  • Headache

13

21

17

  • Viral Infection

1

3

3

Digestive System

  • Dry Mouth

3

5

7

  • Dyspepsia

4

4

5

  • Nausea

4

5

4

  • Vomiting

1

3

0

Nervous System

  • Anxiety

0

3

1

  • Confusion

0

0

3

  • Depression

0

4

1

  • Dizziness

4

5

7

  • Hallucinations

0

1

3

  • Libido Decreased

0

0

3

  • Nervousness

3

5

0

  • Somnolence

3

10

8

Respiratory System

  • Infection

3

5

10

Skin and Appendages

  • Rash

1

3

4

Special Senses

  • Unpleasant Taste

3

17

34

Urogenital System

  • Dysmenorrhea *

0

3

0

  • Gynecomastia **

0

3

0

1 Reactions for which the eszopiclone incidence was equal to or less than placebo are not listed on the table, but included the following: abnormal dreams, accidental injury, back pain, diarrhea, flu syndrome, myalgia, pain, pharyngitis, and rhinitis.
* Gender-specific adverse reaction in females
** Gender-specific adverse reaction in males

Adverse reactions from Table 1 that suggest a dose-response relationship in adults include viral infection, dry mouth, dizziness, hallucinations, infection, rash, and unpleasant taste, with this relationship clearest for unpleasant taste.

Table 2 shows the incidence of adverse reactions from combined Phase 3 placebo-controlled studies of eszopiclone at doses of 1 or 2 mg in elderly adults (ages 65 to 86). Treatment duration in these trials was 14 days. The table includes only reactions that occurred in 2% or more of patients treated with eszopiclone 1 mg or 2 mg in which the incidence in patients treated with eszopiclone was greater than the incidence in placebo-treated patients.

Table 2: Incidence (%) of Adverse Reactions in Elderly Adults (Ages 65 to 86 Years) in 2-Week Placebo-Controlled Trials with Eszopiclone 1

Adverse Reactions

Placebo

(n=208)

Eszopiclone 1 mg

(n=72)

Eszopiclone 2 mg

(n=215)

Body as a Whole

  • Accidental Injury

1

0

3

  • Headache

14

15

13

  • Pain

2

4

5

Digestive System

  • Diarrhea

2

4

2

  • Dry Mouth

2

3

7

  • Dyspepsia

2

6

2

Nervous System

  • Abnormal Dreams

0

3

1

  • Dizziness

2

1

6

  • Nervousness

1

0

2

  • Neuralgia

0

3

0

Skin and Appendages

  • Pruritus

1

4

1

Special Senses

  • Unpleasant Taste

0

8

12

Urogenital System

  • Urinary Tract Infection

0

3

0

1 Reactions for which the eszopiclone incidence was equal to or less than placebo are not listed on the table, but included the following: abdominal pain, asthenia, nausea, rash, and somnolence.

Adverse reactions from Table 2 that suggest a dose-response relationship in elderly adults include pain, dry mouth, and unpleasant taste, with this relationship again clearest for unpleasant taste.

These figures cannot be used to predict the incidence of adverse reactions in the course of usual medical practice because patient characteristics and other factors may differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contributions of drug and nondrug factors to the adverse reaction incidence rate in the population studied.

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