Dalmane Side Effects

Generic Name: flurazepam

Please note - some side effects for Dalmane 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).

Side Effects of Dalmane - for the Consumer

Dalmane

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 Dalmane:

Clumsiness or unsteadiness; dizziness; excessive daytime drowsiness; headache; lightheadedness; stomach upset; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; shortness of breath; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue); bizarre behavior; changes in personality, mood, or behavior; chest pain; confusion; depression; disorientation; fainting; falling; hallucinations; irregular heartbeat; loss of coordination; severe drowsiness; staggering; unusual weakness or tiredness.

Side Effects by Body System

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 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 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. 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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