Temazepam Side Effects
Brand Names: Restoril
Please note - some side effects for Temazepam 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 Temazepam - for the Consumer
Temazepam
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 Temazepam:
Seek medical attention right away if any of these SEVERE side effects occur when using Temazepam:Anxiety; clumsiness or unsteadiness; daytime drowsiness; dizziness; fatigue; feeling of hangover; headache; lightheadedness; nausea; nervousness; sluggishness; unusual weakness.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; hoarseness); confusion; hallucinations; memory loss; mental or mood problems (eg, aggression, agitation, anxiety); new or worsening trouble sleeping; suicidal thoughts or actions; unusual behavior.
Temazepam Side Effects - for the Professional
Temazepam
During controlled clinical studies in which 1,076 patients received Temazepam at bedtime, the drug was well tolerated. Side effects were usually mild and transient. Adverse reactions occurring in 1% or more of patients are presented in the following table:
| Temazepam % of incidence (n = 1,076) |
Placebo % of incidence (n = 783) |
|
| Drowsiness | 9.1 | 5.6 |
| Headache | 8.5 | 9.1 |
| Fatigue | 4.8 | 4.7 |
| Nervousness | 4.6 | 8.2 |
| Lethargy | 4.5 | 3.4 |
| Dizziness | 4.5 | 3.3 |
| Nausea | 3.1 | 3.8 |
| Hangover | 2.5 | 1.1 |
| Anxiety | 2 | 1.5 |
| Depression | 1.7 | 1.8 |
| Dry Mouth | 1.7 | 2.2 |
| Diarrhea | 1.7 | 1.1 |
| Abdominal Discomfort | 1.5 | 1.9 |
| Euphoria | 1.5 | 0.4 |
| Weakness | 1.4 | 0.9 |
| Confusion | 1.3 | 0.5 |
| Blurred Vision | 1.3 | 1.3 |
| Nightmares | 1.2 | 1.7 |
| Vertigo | 1.2 | 0.8 |
The following adverse events have been reported less frequently (0.5% to 0.9%):
Central Nervous System: anorexia, ataxia, equilibrium loss, tremor, increased dreaming
Cardiovascular: dyspnea, palpitations
Gastrointestinal: vomiting
Musculoskeletal: backache
Special Senses: hyperhidrosis, burning eyes
Amnesia, hallucinations, horizontal nystagmus and paradoxical reactions including restlessness, overstimulation and agitation were rare (less than 0.5%).
TopSide Effects by Body System
Nervous system
Nervous system side effects are common and include drowsiness (9.1%), headache (8.5%), fatigue (4.8%), nervousness (4.6%), dizziness (4.5%), and lethargy (4.5%) most frequently. Sleep disturbances, morning "hangover" symptoms, hyperexcitability, confusion, amnesia, and ataxia have also been observed.
One population- based case control study has suggested that use of temazepam in elderly patients may be associated with an increased risk of hip fractures.
Other
Withdrawal symptoms may include agitation, restlessness, anxiety, insomnia, convulsions, tremor, abdominal cramps, blurred vision, vomiting, and sweating.
Other side effects include withdrawal symptoms after either abrupt cessation or fast tapering of temazepam. Rebound insomnia (a worsening of sleep following cessation of therapy) has also been reported but appears to be less common with temazepam than other benzodiazepines used for hypnosis. Death from pulmonary microembolization has been reported in one patient who crushed temazepam tablets and injected them intravenously. Limb ischemia requiring amputation has also been reported following inadvertent intra-arterial administration of temazepam in drug abusing patients.
Psychiatric
Psychiatric side effects including cognitive disturbances, psychotic symptoms, and euphoria have been reported. One case of visual hallucination has been reported and confirmed upon rechallenge.
Hepatic
Hepatic side effects including hepatitis and elevated liver function tests have been reported rarely.
Gastrointestinal
Gastrointestinal side effects including diarrhea, constipation, nausea, and vomiting have been reported rarely.
Hematologic
Hematologic side effects including blood dyscrasias have been reported rarely.
Hypersensitivity
Hypersensitivity side effects including anaphylaxis have been reported rarely.
TopMore resources:
Temazepam - Includes detailed dosage instructions.
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