Prosom Side Effects
Generic Name: Estazolam
Please note - some side effects for Prosom may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Prosom - for the consumer
Prosom
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Prosom:
Seek medical attention right away if any of these SEVERE side effects occur when using Prosom:Clumsiness or unsteadiness; daytime drowsiness; dizziness; fatigue; feeling of hangover; headache; lightheadedness; nausea; nervousness; sluggishness; unusual weakness.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); depression; chills, fever, or sore throat; fast or irregular heartbeat; hallucinations; memory loss; mental or mood changes; shortness of breath; unusual bruising; unusual thoughts or behaviors; urinary changes; vision changes.
For the professional
Prosom
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.
| Body System/ Adverse Event* |
Prosom (N=685) |
Placebo (N=433) |
* Events reported by at least 1% of Prosom patients. | ||
| Body as a Whole | ||
| Headache | 16 | 27 |
| Asthenia | 11 | 8 |
| Malaise | 5 | 5 |
| Lower extremity pain | 3 | 2 |
| Back pain | 2 | 2 |
| Body pain | 2 | 2 |
| Abdominal pain | 1 | 2 |
| Chest pain | 1 | 1 |
| Digestive System | ||
| Nausea | 4 | 5 |
| Dyspepsia | 2 | 2 |
| Musculoskeletal System | ||
| Stiffness | 1 | - |
| Nervous System | ||
| Somnolence | 42 | 27 |
| Hypokinesia | 8 | 4 |
| Nervousness | 8 | 11 |
| Dizziness | 7 | 3 |
| Coordination abnormal | 4 | 1 |
| Hangover | 3 | 2 |
| Confusion | 2 | - |
| Depression | 2 | 3 |
| Dream abnormal | 2 | 2 |
| Thinking abnormal | 2 | 1 |
| Respiratory System | ||
| Cold symptoms | 3 | 5 |
| Pharyngitis | 1 | 2 |
| Skin and Appendages | ||
| Pruritus | 1 | - |
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 WholeInfrequent
allergic reaction, chills, fever, neck pain, upper extremity pain
Rare
edema, jaw pain, swollen breast.
Cardiovascular SystemInfrequent
flushing, palpitation
Rare
arrhythmia, syncope.
Digestive SystemFrequent
constipation, dry mouth
Infrequent
decreased appetite, flatulence, gastritis, increased appetite, vomiting
Rare
enterocolitis, melena, ulceration of the mouth.
Endocrine SystemRare
thyroid nodule.
Hematologic and Lymphatic SystemRare
leukopenia, purpura, swollen lymph nodes.
Metabolic/Nutritional DisordersInfrequent
thirst
Rare
increased SGOT, weight gain, weight loss.
Musculoskeletal SystemInfrequent
arthritis, muscle spasm, myalgia
Rare
arthralgia.
Nervous SystemFrequent
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 SystemInfrequent
asthma, cough, dyspnea, rhinitis, sinusitis
Rare
epistaxis, hyperventilation, laryngitis.
Skin and AppendagesInfrequent
rash, sweating, urticaria
Rare
acne, dry skin.
Special SensesInfrequent
abnormal vision, ear pain, eye irritation, eye pain, eye swelling, perverse taste, photophobia, tinnitus
Rare
decreased hearing, diplopia, scotomata.
Urogenital SystemInfrequent
frequent urination, menstrual cramps, urinary hesitancy, urinary urgency, vaginal discharge/itching
Rare
hematuria, nocturia, oliguria, penile discharge, urinary incontinence.
Postintroduction ReportsVoluntary 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.
TopMore resources:
ProSom - Includes detailed dosage instructions.
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