Dalmane Side Effects

Generic name: flurazepam

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

Some side effects of Dalmane 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 flurazepam: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking flurazepam (the active ingredient contained in Dalmane) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• feeling like you might pass out;

• staggering walk, loss of balance or coordination;

• agitation, confusion, slurred speech, hallucinations, feelings of extreme happiness or sadness;

• chest pain, fast or pounding heartbeats, feeling short of breath;

• fever, chills, body aches, flu symptoms;

• problems with urination;

• vision problems, burning in your eyes; or

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

Less serious side effects of flurazepam may include:

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

• headache, blurred vision, depressed mood;

• stomach pain, heartburn, upset stomach, nausea, vomiting, diarrhea, constipation;

• feeling nervous, excited, or irritable;

• increased sweating;

• flushing (warmth, redness, or tingly feeling);

• mild itching or rash; or

• dry mouth, unpleasant taste in your mouth.

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 flurazepam: oral capsule

Nervous system

Nervous system side effects have been common and most frequently have included drowsiness, dizziness, and sedation. Headache, anterograde amnesia, hyperexcitability, cognitive disturbances, oral-buccal dyskinesia, and ataxia have also been observed.

Flurazepam may cause a greater degree of sedation and psychomotor impairment in older patients compared to other benzodiazepines commonly used as hypnotics. The reason for this increased sensitivity may be related to a prolonged elimination half-life of desalkylflurazepam in elderly patients. One study has suggested that elderly patients who experienced a fall in the hospital were more likely to be taking flurazepam than those elderly patients who did not experience a fall.

Psychiatric

Psychiatric side effects have included confusion, agitation, depression, secondary mania, and hallucinations.

Other

Other side effects have included tolerance to the pharmacologic effects of flurazepam (the active ingredient contained in Dalmane) and withdrawal symptoms after either abrupt cessation or fast tapering of flurazepam. Withdrawal symptoms may include agitation, restlessness, anxiety, depression, insomnia, tremor, abdominal discomfort, blurred vision, vomiting, and sweating. Psychosis, delirium, and seizures have been observed during withdrawal from other benzodiazepines.

Daytime sedation and, less frequently, rebound insomnia (a worsening of sleep following cessation of therapy) and other sleep disturbances have been reported.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, bad taste, dry mouth, constipation, and diarrhea. Many of these symptoms have occurred at frequencies similar to or less than placebo.

Respiratory

Respiratory side effects have included cases of respiratory depression manifested by an increase in the number of obstructive apneas during sleep.

Hepatic

Hepatic side effects have included several cases of intrahepatic cholestasis.

Hypersensitivity

Hypersensitivity side effects to flurazepam (the active ingredient contained in Dalmane) have rarely been reported.

A number of case reports have suggested that flurazepam may cause a drug-induced encephalopathy in patients with end-stage renal disease undergoing hemodialysis. Specific findings reported include altered consciousness, asterixis, abnormal EEG, and in one patient, biochemical evidence of liver disease.

Local

Local side effects have included a case of peripheral ischemia following injection of flurazepam (the active ingredient contained in Dalmane) In that case, a known intravenous drug abuser crushed oral flurazepam tablets (and possibly other tablets) and injected them into a finger. Distal necrosis ensued and required amputation of the affected finger.

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