Estazolam Side Effects

Some side effects of estazolam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to estazolam: oral tablet

Estazolam may cause a severe allergic reaction. Stop taking estazolam and Get emergency medical help if you have any of these signs of an allergic reaction while taking estazolam: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using estazolam and call your doctor at once if you have any of these serious side effects:

• weak or shallow breathing;

• fast or pounding heartbeats;

• confusion, slurred speech, unusual thoughts or behavior;

• hallucinations, agitation, aggression;

• thoughts of suicide or hurting yourself;

• restless muscle movements in your eyes, tongue, jaw, or neck;

• pale skin, easy bruising or bleeding, unusual weakness;

• fever, chills, body aches, flu symptoms;

• problems with urination; or

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects of estazolam may include:

• daytime drowsiness (or during hours when you are not normally sleeping);

• amnesia or forgetfulness;

• muscle weakness, lack of balance or coordination;

• numbness, burning, pain, or tingly feeling;

• headache, blurred vision, depressed mood;

• feeling nervous, excited, or irritable;

• nausea, vomiting, stomach discomfort; or

• dry mouth, increased thirst.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to estazolam: oral tablet

Nervous system

Two cases of seizures following discontinuation of estazolam have been reported.

Nervous system side effects have been common and included drowsiness, sedation, headache, dizziness, hypokinesia, and ataxia most frequently. Anxiety has also been reported.

Other

Other side effects have included tolerance to the pharmacologic effects of benzodiazepines and withdrawal symptoms after either abrupt cessation or fast tapering of estazolam. Withdrawal symptoms have included agitation, restlessness, anxiety, depression, insomnia, tremor, abdominal discomfort, blurred vision, vomiting, sweating, and seizures.

Respiratory

However, one study of single high doses of estazolam given to healthy volunteers revealed no evidence of respiratory depression during wakefulness.

Respiratory side effects have included dose-dependent respiratory depression. Estazolam-induced respiratory depression is generally not clinically significant at the usual hypnotic doses. However, patients with impaired respiratory function may be at greater risk of estazolam-induced respiratory depression.

Gastrointestinal

Gastrointestinal symptoms including nausea, constipation, bad taste in mouth, and dry mouth have been reported.

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