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Prosom Side Effects

Generic name: estazolam

Medically reviewed by Drugs.com. Last updated on Jan 11, 2021.

Note: This document contains side effect information about estazolam. Some of the dosage forms listed on this page may not apply to the brand name Prosom.

For the Consumer

Applies to estazolam: oral tablet

Warning

Oral route (Tablet)

Warning: Risks From Concomitant Use With Opioids; Abuse, Misuse, and Addiction; and Dependence and Withdrawal ReactionsConcomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.The use of benzodiazepines, including estazolam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing estazolam and throughout treatment, assess each patient's risk for abuse, misuse, and addiction.The continued use of benzodiazepines, including estazolam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of estazolam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue estazolam or reduce the dosage.

Side effects requiring immediate medical attention

Along with its needed effects, estazolam (the active ingredient contained in Prosom) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking estazolam:

More common

  • Absence of or decrease in body movement
  • clumsiness or unsteadiness
  • dizziness
  • sleepiness or unusual drowsiness

Less common

  • Dry mouth
  • false beliefs that cannot be changed by facts
  • headache
  • mood or mental changes
  • nausea and vomiting
  • poor insight and judgment
  • problems with memory or speech
  • tiredness
  • trouble thinking and planning
  • trouble walking

Rare

  • Aggressive or angry
  • blood in the urine
  • bloody nose
  • bloody, black, or tarry stools
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain or tightness
  • chills
  • cough
  • crying
  • decrease in the amount of urine
  • decreased awareness or responsiveness
  • decreased reflexes
  • deep or fast breathing with dizziness
  • difficult urination
  • dryness or soreness of throat
  • dysphoria
  • fainting
  • false or unusual sense of well-being
  • fast, irregular, pounding, or racing heartbeat or pulse
  • fear or nervousness
  • feeling of unreality
  • feeling of warmth
  • fever
  • frequent strong or increased urge to urinate
  • hoarseness
  • increased urge to urinate during the night
  • irritability
  • lack of feeling or emotion
  • loss of bladder control
  • loss of memory
  • mouth sores or ulcers
  • muscle spasm or jerking of all extremities
  • noisy breathing
  • numbness of the feet, hands, and around mouth
  • paranoia
  • problems with memory
  • quick to react or overreact emotionally
  • rapidly changing moods
  • redness of the face, neck, arms, and occasionally, upper chest
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • seizures
  • sense of detachment from self or body
  • severe sleepiness
  • severe stomach pain
  • shakiness and unsteady walk
  • shakiness in the legs, arms, hands, or feet
  • skin rash
  • sores, ulcers, or white spots on the lips or in the mouth
  • sudden loss of consciousness
  • swelling
  • swollen glands
  • swollen lymph nodes
  • trouble breathing
  • trouble in swallowing
  • trouble sleeping
  • uncaring
  • uncontrolled eye movements
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • voice changes
  • waking to urinate at night

Incidence not known

  • Blistering, peeling, or loosening of the skin
  • diarrhea
  • fever with or without chills
  • general feeling of tiredness or weakness
  • itching
  • joint or muscle pain
  • lower back or side pain
  • muscle cramps
  • red, irritated eyes
  • red skin lesions, often with a purple center
  • sleeplessness
  • sweating
  • unable to sleep

Get emergency help immediately if any of the following symptoms of overdose occur while taking estazolam:

Symptoms of overdose

  • Change in consciousness
  • irregular, fast or slow, or shallow breathing
  • pale or blue lips, fingernails, or skin
  • slurred speech

Side effects not requiring immediate medical attention

Some side effects of estazolam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Lack or loss of strength

Less common

  • Pain in the legs or feet

Rare

  • Blemishes on the skin
  • bloated
  • blurred vision
  • burning feeling in the chest or stomach
  • change in color vision
  • change in taste bad unusual or unpleasant (after) taste
  • changes in vision, especially night blindness
  • continuing ringing or buzzing or other unexplained noise in the ears
  • cramping in the lower stomach, back, or legs
  • decreased interest in sexual intercourse
  • difficulty having a bowel movement (stool)
  • difficulty in moving
  • difficulty seeing at night
  • double vision
  • ear or eye pain
  • excess air or gas in stomach or intestines
  • full feeling
  • glare or snowy image caused by bright light
  • hearing loss
  • hives or welts
  • inability to have or keep an erection
  • increased or decreased appetite
  • increased sensitivity of eyes to sunlight
  • indigestion
  • loss in sexual ability, desire, drive, or performance
  • muscle pains or stiffness
  • pain in the arms, jaw, or neck
  • pain or tenderness around the eyes and cheekbones
  • pain, swelling, or redness in joints
  • passing gas
  • pimples
  • red, sore eyes
  • redness of the skin
  • seeing double
  • sneezing
  • stomach upset or tenderness
  • stuffy or runny nose
  • swelling of the breasts
  • weight gain or loss
  • white or brownish vaginal discharge

Incidence not known

  • Increased sensitivity of skin to sunlight
  • redness or other discoloration of skin
  • severe sunburn

For Healthcare Professionals

Applies to estazolam: oral tablet

General

The most commonly reported side effects were somnolence, hypokinesia, dizziness, and abnormal coordination.[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reaction[Ref]

Psychiatric

Very common (10% or more): Somnolence (42%)

Common (1% to 10%): Anxiety, depression, abnormal dream, abnormal thinking

Uncommon (0.1% to 1%): Agitation, apathy, emotional lability, euphoria, hostility, sleep disorder

Rare (less than 0.1%): Hallucinations[Ref]

Nervous system

Very common (10% or more): Headache (16%)

Common (1% to 10%): Hypokinesia, nervousness, dizziness, abnormal coordination, hangover, confusion

Uncommon (0.1% to 1%): Amnesia, paresthesia, seizure, stupor, twitch

Rare (less than 0.1%): Ataxia, circumoral paresthesia, decreased reflexes, neuritis, nystagmus, tremor

Frequency not reported: Minor changes in EEG patterns[Ref]

Hepatic

Rare (less than 0.1%): Increased SGOT[Ref]

Other

Very common (10% or more): Asthenia (11%)

Common (1% to 10%): Malaise, body pain

Uncommon (0.1% to 1%): Chills, fever, ear pain, perverse taste, tinnitus

Rare (less than 0.1%): Edema, decreased hearing[Ref]

Respiratory

Common (1% to 10%): Cold symptoms, pharyngitis

Uncommon (0.1% to 1%): Asthma, cough, dyspnea, rhinitis, sinusitis

Rare (less than 0.1%): Epistaxis, hyperventilation, laryngitis[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, dry mouth, nausea, dyspepsia

Uncommon (0.1% to 1%): Decreased appetite, flatulence, gastritis, increased appetite, vomiting

Rare (less than 0.1%): Enterocolitis, melena, ulceration of the mouth[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Flushing, palpitation

Rare (less than 0.1%): Arrhythmia, syncope[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, sweating, urticaria

Rare (less than 0.1%): Acne, dry skin

Postmarketing reports: Stevens-Johnson syndrome, photosensitivity[Ref]

Endocrine

Rare (less than 0.1%): Thyroid nodule[Ref]

Genitourinary

Uncommon (0.1% to 1%): Frequent urination, menstrual cramps, urinary hesitancy, urinary urgency, vaginal discharge/itching

Rare (less than 0.1%): Swollen breast, decreased libido, hematuria, nocturia, oliguria, penile discharge, urinary incontinence[Ref]

Hematologic

Rare (less than 0.1%): Leukopenia, purpura, swollen lymph nodes

Postmarketing reports: Agranulocytosis[Ref]

Metabolic

Uncommon (0.1% to 1%): Thirst

Rare (less than 0.1%): Weight gain, weight loss[Ref]

Musculoskeletal

Common (1% to 10%): Lower extremity pain, back pain, stiffness

Uncommon (0.1% to 1%): Neck pain, upper extremity pain, arthritis, muscle spasm, myalgia

Rare (less than 0.1%): Jaw pain, arthralgia[Ref]

Ocular

Uncommon (0.1% to 1%): Abnormal vision, eye irritation, eye pain, eye swelling, photophobia

Rare (less than 0.1%): Diplopia, scotomata[Ref]

References

1. "Product Information. ProSom (estazolam)." Abbott Pharmaceutical, Abbott Park, IL.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.