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Prosom (Estazolam) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Commonly Observed

The most commonly observed adverse events associated with the use of ProSom, not seen at an equivalent incidence among placebo-treated patients were somnolence, hypokinesia, dizziness, and abnormal coordination.

Associated with Discontinuation of Treatment

Approximately 3% of 1277 patients who received ProSom in US premarketing clinical trials discontinued treatment because of an adverse clinical event. The only event commonly associated with discontinuation, accounting for 1.3% of the total, was somnolence.

Incidence in Controlled Clinical Trials

The table below enumerates adverse events that occurred at an incidence of 1% or greater among patients with insomnia who received ProSom in 7-night, placebo-controlled trials. Events reported by investigators were classified into standard dictionary (COSTART) terms to establish event frequencies. Event frequencies reported were not corrected for the occurrence of these events at baseline. The frequencies were obtained from data pooled across six studies: ProSom, N=685; placebo, N=433. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice in which patient characteristics and other factors differ from those that prevailed in these six clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigators involving related drug products and uses, since each group of drug trials was conducted under a different set of conditions. However, the cited figures provide the physician with a basis of estimating the relative contribution of drug and nondrug factors to the incidence of side effects in the population studied.

Incidence of Adverse Experiences in Placebo-Controlled Clinical Trials (Percentage of Patients Reporting)
Body System/
Adverse Event*
ProSom
(N=685)
Placebo
(N=433)

*   Events reported by at least 1% of ProSom patients.

Body as a Whole
   Headache1627
   Asthenia118
   Malaise55
   Lower extremity pain32
   Back pain22
   Body pain22
   Abdominal pain12
   Chest pain11
   Digestive System
   Nausea45
   Dyspepsia22
Musculoskeletal System
   Stiffness1-
Nervous System
   Somnolence4227
   Hypokinesia84
   Nervousness811
   Dizziness73
   Coordination abnormal41
   Hangover32
   Confusion2-
   Depression23
   Dream abnormal22
   Thinking abnormal21
Respiratory System
   Cold symptoms35
   Pharyngitis12
Skin and Appendages
   Pruritus1-

Other Adverse Events

During clinical trials conducted by Abbott, some of which were not placebo − controlled, ProSom was administered to approximately 1300 patients. Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals experiencing adverse events, similar types of untoward events must be grouped into a smaller number of standardized event categories. In the tabulations that follow, a standard COSTART dictionary terminology has been used to classify reported adverse events. The frequencies presented, therefore, represent the proportion of the 1277 individuals exposed to ProSom who experienced an event of the type cited on at least one occasion while receiving ProSom. All reported events are included except those already listed in the previous table, those COSTART terms too general to be informative, and those events where a drug cause was remote. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in less than 1/1000 patients. It is important to emphasize that, although the events reported did occur during treatment with ProSom, they were not necessarily caused by it.

Body as a Whole

Infrequent

allergic reaction, chills, fever, neck pain, upper extremity pain

Rare

edema, jaw pain, swollen breast.

Cardiovascular System

Infrequent

flushing, palpitation

Rare

arrhythmia, syncope.

Digestive System

Frequent

constipation, dry mouth

Infrequent

decreased appetite, flatulence, gastritis, increased appetite, vomiting

Rare

enterocolitis, melena, ulceration of the mouth.

Endocrine System

Rare

thyroid nodule.

Hematologic and Lymphatic System

Rare

leukopenia, purpura, swollen lymph nodes.

Metabolic/Nutritional Disorders

Infrequent

thirst

Rare

increased SGOT, weight gain, weight loss.

Musculoskeletal System

Infrequent

arthritis, muscle spasm, myalgia

Rare

arthralgia.

Nervous System

Frequent

anxiety

Infrequent

agitation, amnesia, apathy, emotional lability, euphoria, hostility, paresthesia, seizure, sleep disorder, stupor, twitch

Rare

ataxia, circumoral paresthesia, decreased libido, decreased reflexes, hallucinations, neuritis, nystagmus, tremor.

Minor changes in EEG patterns, usually low-voltage fast activity, have been observed in patients during ProSom therapy or withdrawal and are of no known clinical significance.

Respiratory System

Infrequent

asthma, cough, dyspnea, rhinitis, sinusitis

Rare

epistaxis, hyperventilation, laryngitis.

Skin and Appendages

Infrequent

rash, sweating, urticaria

Rare

acne, dry skin.

Special Senses

Infrequent

abnormal vision, ear pain, eye irritation, eye pain, eye swelling, perverse taste, photophobia, tinnitus

Rare

decreased hearing, diplopia, scotomata.

Urogenital System

Infrequent

frequent urination, menstrual cramps, urinary hesitancy, urinary urgency, vaginal discharge/itching

Rare

hematuria, nocturia, oliguria, penile discharge, urinary incontinence.

Postintroduction Reports

Voluntary reports of non-US postmarketing experience with estazolam have included rare occurrences of photosensitivity, Stevens-Johnson syndrome, and agranulocytosis. Because of the uncontrolled nature of these spontaneous reports, a causal relationship to estazolam treatment has not been determined.

Drug label data at the top of this Page last updated: 2006-06-16

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