April 28, 2017
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Prosom

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Prosom




Prosom Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 03/23/2017

Prosom (estazolam) is an oral hypnotic agent indicated for the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. Common side effects of Prosom include:

  • sleepiness,
  • hypokinesia,
  • dizziness,
  • abnormal coordination,
  • headache,
  • weakness,
  • feeling unwell (malaise),
  • lower extremity pain,
  • back pain,
  • chest pain,
  • nausea,
  • indigestion,
  • muscle stiffness,
  • dizziness,
  • confusion,
  • depression,
  • abnormal thinking,
  • abnormal dreams,
  • cold symptoms,
  • sore throat, and
  • itching.

The recommended initial dose of Prosom for adults is 1 mg at bedtime; however, some patients may need a 2 mg dose. Prosom may interact with ketoconazole, itraconazole, anticonvulsants, antihistamines, alcohol, smoking, barbiturates, monoamine oxidase inhibitors, narcotics, phenothiazines, psychotropic medications, other drugs that produce CNS depression, smoking, nefazodone, fluvoxamine, cimetidine, diltiazem, isoniazide, and some macrolide antibiotics. Tell your doctor all medications and supplements you use. Prosom is not recommended for use during pregnancy; it may harm a fetus. It is unknown if Prosom passes into breast milk. Breastfeeding while using Prosom is not recommended. Withdrawal symptoms may occur if you suddenly stop taking Prosom.

Our Prosom (estazolam) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Prosom FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Commonly Observed

The most commonly observed adverse events associated with the use of estazolam, 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 estazolam 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 estazolam in 7-night, placebocontrolled 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: estazolam, 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*
Estazolam
(N=685)
Placebo
(N=433)
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 42 27
  Somnolence 8 4
  Hypokinesia 8 11
  Nervousness 7 3
  Dizziness 4 1
Coordination abnormal
  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 -
* Events reported by at least 1% of estazolam patients.

Other Adverse Events

During clinical trials, some of which were not placebo-controlled, estazolam 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 estazolam who experienced an event of the type cited on at least one occasion while receiving estazolam. 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 estazolam, 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 estazolam 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.

To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Read the entire FDA prescribing information for Prosom (Elprazolam Tablet)

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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