Clonazepam (Page 4 of 7)

Panic Disorder

Adverse events during exposure to clonazepam were obtained by spontaneous report and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, CIGY dictionary terminology has been used to classify reported adverse events, except in certain cases in which redundant terms were collapsed into more meaningful terms, as noted below.

The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Adverse Findings Observed in Short-Term, Placebo-Controlled Trials

Adverse Events Associated With Discontinuation of Treatment

Overall, the incidence of discontinuation due to adverse events was 17% in clonazepam compared to 9% for placebo in the combined data of two 6 to 9 week trials. The most common events (≥ 1%) associated with discontinuation and a dropout rate twice or greater for clonazepam than that of placebo included the following:

Table 2: Most Common Adverse Events (≥ 1%) Associated With Discontinuation of Treatment

Adverse Event

Clonazepam (N = 574)

Placebo (N = 294)

Somnolence

7%

1%

Depression

4%

1%

Dizziness

1%

< 1%

Nervousness

1%

0%

Ataxia

1%

0%

Intellectual Ability Reduced

1%

0%

Adverse Events Occurring at an Incidence of 1% or More Among Clonazepam-Treated Patients

Table 3 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy of panic disorder from a pool of two 6 to 9 week trials. Events reported in 1% or more of patients treated with clonazepam (doses ranging from 0.5 to 4 mg/day) and for which the incidence was greater than that in placebo-treated patients are included.

The prescriber should be aware that the figures in Table 3 cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors 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 contribution of drug and nondrug factors to the side effect incidence in the population studied.

Table 3: Treatment-Emergent Adverse Event Incidence in 6 to 9 Week Placebo-Controlled Clinical Trials *
*
Events reported by at least 1% of patients treated with clonazepam and for which the incidence was greater than that for placebo.
Indicates that the p-value for the dose-trend test (Cochran-Mantel-Haenszel) for adverse event incidence was ≤ 0.10.
Denominators for events in gender-specific systems are: n = 240 (clonazepam), 102 (placebo) for male, and 334 (clonazepam), 192 (placebo) for female.

Clonazepam Maximum Daily Dose

All

Clonazepam

< 1 mg

1 to < 2 mg

2 to < 3 mg

≥ 3 mg

Groups

Placebo

Adverse Event

n = 96

n = 129

n = 113

n = 235

N = 574

N = 294

by Body System

%

%

%

%

%

%

Central & Peripheral Nervous System

Somnolence

26

35

50

36

37

10

Dizziness

5

5

12

8

8

4

Coordination Abnormal

1

2

7

9

6

0

Ataxia

2

1

8

8

5

0

Dysarthria

0

0

4

3

2

0

Psychiatric

Depression

7

6

8

8

7

1

Memory Disturbance

2

5

2

5

4

2

Nervousness

1

4

3

4

3

2

Intellectual Ability Reduced

0

2

4

3

2

0

Emotional Lability

0

1

2

2

1

1

Libido Decreased

0

1

3

1

1

0

Confusion

0

2

2

1

1

0

Respiratory System

Upper Respiratory Tract Infection

10

10

7

6

8

4

Sinusitis

4

2

8

4

4

3

Rhinitis

3

2

4

2

2

1

Coughing

2

2

4

0

2

0

Pharyngitis

1

1

3

2

2

1

Bronchitis

1

0

2

2

1

1

Gastrointestinal System

Constipation

0

1

5

3

2

2

Appetite Decreased

1

1

0

3

1

1

Abdominal Pain

2

2

2

0

1

1

Body as a Whole

Fatigue

9

6

7

7

7

4

Allergic Reaction

3

1

4

2

2

1

Musculoskeletal

Myalgia

2

1

4

0

1

1

Resistance Mechanism Disorders

Influenza

3

2

5

5

4

3

Urinary System

Micturition Frequency

1

2

2

1

1

0

Urinary Tract Infection

0

0

2

2

1

0

Vision Disorders

Blurred Vision

1

2

3

0

1

1

Reproductive Disorders

Female

Dysmenorrhea

0

6

5

2

3

2

Colpitis

4

0

2

1

1

1

Male

Ejaculation Delayed

0

0

2

2

1

0

Impotence

3

0

2

1

1

0

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