Side Effects of Restoril (temazepam)
Restoril (temazepam) is a benzodiazepine used to treat anxiety. Restoril and other benzodiazepines enhance the effects of gamma-aminobutyric acid (GABA) in the brain.
GABA is a neurotransmitter that inhibits brain activity. Excessive brain activity can cause anxiety or other psychiatric disorders, which Restoril reduces. Restoril also increases total sleep time.
Common side effects of Restoril:
- excessive sleepiness,
- dizziness,
- weakness,
- unsteadiness.
Other important side effects of Restoril:
- depression,
- loss of orientation,
- headache,
- sleep disturbances.
Drug interactions of Restoril include alcohol or drugs that cause sleepiness, which can increase its effects.
Restoril and other benzodiazepines have been associated with fetal damage when taken by pregnant women in their first trimester. Restoril should be avoided during pregnancy. Use of Restoril by nursing mothers has not been adequately studied. Consult your doctor before breastfeeding.
What are the important side effects of Restoril (temazepam)?
The most common side effects of temazepam are:
- excessive sleepiness,
- dizziness,
- weakness,
- unsteadiness.
Other important side effects include:
- depression,
- loss of orientation,
- headache,
- sleep disturbances.
Restoril (temazepam) side effects list for healthcare professionals
During controlled clinical studies, Restoril 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:
| Restoril % Incidence (n=1076) |
Placebo % 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 | 2.0 | 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 (restlessness, overstimulation, and agitation) were rare (less than 0.5%).
What drugs interact with Restoril (temazepam)?
The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression. Benzodiazepines interact at GABAA sites and opioids interact primarily at mu receptors.
Limit dosage and duration of concomitant use of benzodiazepines and opioids. Monitor patients closely for respiratory depression and sedation.
The pharmacokinetic profile of temazepam does not appear to be altered by orally administered cimetidine dosed according to labeling.
Drug Abuse And Dependence
Abuse and addiction are separate from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Physical dependence is a state of adaptation manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist.
Tolerance is a state of adaptation where exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time.
Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, but relapse is common.
Controlled Substance
Restoril is a controlled substance in Schedule IV.
Abuse And Dependence
Withdrawal symptoms similar to barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting, and sweating) have occurred following abrupt discontinuance of benzodiazepines. Milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of therapeutic-level benzodiazepines. After extended therapy at doses higher than 15 mg, gradual dosage tapering should be followed. Caution must be exercised in administering Restoril to individuals known to be addiction-prone.
Summary
Restoril (temazepam) is a benzodiazepine used to treat anxiety. Restoril and other benzodiazepines enhance the effects of GABA in the brain. Common side effects of Restoril include excessive sleepiness, dizziness, weakness, and unsteadiness. Other important side effects of Restoril include depression, loss of orientation, headache, and sleep disturbances. Restoril and other benzodiazepines have been associated with fetal damage when taken by pregnant women in their first trimester. Restoril should be avoided during pregnancy. Use of Restoril by nursing mothers has not been adequately studied.
