Temazepam Side Effects

It is possible that some side effects of temazepam may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to temazepam: oral capsule, oral tablet

As well as its needed effects, temazepam may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking temazepam, check with your doctor immediately:

Less common
  • False or unusual sense of well-being
  • fear or nervousness
  • mood or mental changes
Rare
  • Difficult or labored breathing
  • fast, irregular, pounding, or racing heartbeat or pulse
  • loss of appetite
  • loss of memory
  • nightmares
  • problems with memory
  • seeing, hearing, or feeling things that are not there
  • shakiness and unsteady walk
  • shortness of breath
  • tightness in the chest
  • trouble sleeping
  • uncontrolled eye movements
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual excitement, nervousness, restlessness, or irritability
  • weight loss
  • wheezing
Incidence not known
  • Muscle cramps
  • seizures
  • shakiness in the legs, arms, hands, or feet
  • stomach cramps
  • sweating
  • trembling or shaking of the hands or feet
  • vomiting

If any of the following symptoms of overdose occur while taking temazepam, get emergency help immediately:

Symptoms of overdose
  • Blurred vision
  • change in consciousness
  • confusion
  • decreased or absent reflexes
  • difficult or troubled breathing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • irregular, fast, slow, or shallow breathing
  • loss of consciousness
  • pale or blue lips, fingernails, or skin
  • shortness of breath
  • sleepiness or unusual drowsiness
  • unusual tiredness or weakness

Some temazepam side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common
  • Diarrhea
  • dry mouth
  • feeling of constant movement of self or surroundings
  • headache
  • nausea
  • sensation of spinning
  • unusual dullness or feeling of sluggishness
Rare
  • Backache
  • burning eyes

For Healthcare Professionals

Applies to temazepam: oral capsule

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.[Ref]

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.[Ref]

Other

Withdrawal symptoms may include agitation, restlessness, anxiety, insomnia, convulsions, tremor, abdominal cramps, blurred vision, vomiting, and sweating.[Ref]

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.[Ref]

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.[Ref]

Hepatic

Hepatic side effects including hepatitis and elevated liver function tests have been reported rarely.[Ref]

Gastrointestinal

Gastrointestinal side effects including diarrhea, constipation, nausea, and vomiting have been reported rarely.[Ref]

Hematologic

Hematologic side effects including blood dyscrasias have been reported rarely.[Ref]

Hypersensitivity

Hypersensitivity side effects including anaphylaxis have been reported rarely.[Ref]

References

1. Iraqi A, Hughes TL "Visual hallucination and temazepam: an unusual case." J Am Geriatr Soc 54 (2006): 1627-8

2. Roth T, Roehrs TA "A review of the safety profiles of benzodiazepine hypnotics." J Clin Psychiatry 52 (1991): 38-41

3. Bixler EO, Kales A, Brubaker BH, Kales JD "Adverse reactions to benzodiazepine hypnotics: spontaneous reporting system." Pharmacology 35 (1987): 286-300

4. MacKinnon GL, Parker WA "Benzodiazepine withdrawal syndrome: a literature review and evaluation." Am J Drug Alcohol Abuse 9 (1982): 19-33

5. Dodd TJ, Scott RN, Woodburn KR, Going JJ "Limb ischaemia after intra-arterial injection of temazepam gel: histology of nine cases." J Clin Pathol 47 (1994): 512-4

6. Kales A, Manfredi RL, Vgontzas AN, Bixler EO, Vela-Bueno A, Fee EC "Rebound insomnia after only brief and intermittent use of rapidly eliminated benzodiazepines." Clin Pharmacol Ther 49 (1991): 468-76

7. Vella EJ, Edwards CW "Death from pulmonary microembolisation after intravenous injection of temazepam." BMJ 307 (1993): 26

8. Ghabrial H, Desmond PV, Watson KJ, et al "The effects of age and chronic liver disease on the elimination of temazepam." Eur J Clin Pharmacol 30 (1986): 93-7

9. "Product Information. Restoril (temazepam)." Sandoz Pharmaceuticals Corporation, East Hanover, NJ.

10. Mills PJ "Anaphylactoid reaction to oral premedication with temazepam and promethazine ." Anaesthesia 43 (1988): 66

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