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Restoril

Last reviewed on RxList: 1/4/2016
Restoril Side Effects Center

Last reviewed on RxList 7/8/2016

Restoril (temazepam) is a benzodiazepine sedative hypnotic used to treat insomnia symptoms, such as trouble falling or staying asleep. Restoril is available in generic form. Common side effects of Restoril include:

  • dizziness
  • daytime drowsiness (or during hours when you are not normally sleeping)
  • amnesia or forgetfulness
  • muscle weakness
  • loss of balance or coordination
  • headache
  • blurred vision
  • depression
  • nervousness
  • excitability
  • irritability
  • nausea
  • vomiting
  • stomach discomfort
  • dry mouth
  • increased thirst, or
  • numbness
  • burning
  • pain, or
  • tingly feeling

Tell your doctor if you experience serious side effects of Restoril including weak or shallow breathing, fast or pounding heartbeats, confusion, slurred speech, unusual thoughts or behavior, hallucinations, agitation, aggression, thoughts of suicide or hurting yourself, restless muscle movements (in your eyes, tongue, jaw, or neck), pale skin, easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms, problems with urination, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

The usual recommended usual adult dose of Restoril is 15 mg before retiring, though 7.5 mg may be sufficient for some patients, and others may need 30 mg. Restoril may interact with fluvoxamine, itraconazole, ketoconazole, nefazodone, or other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). Tell your doctor all medication you use. Restoril must not be used during pregnancy. Other medications in this class have caused birth defects when used in the first three months of pregnancy, and have also caused unusual drowsiness, feeding problems, and liver problems in newborns when used at or near the time of delivery, or withdrawal symptoms in newborns when used for a long time during pregnancy. Use birth control while taking this drug. This medication passes into breast milk. Consult your doctor before breast-feeding. Withdrawal symptoms (such as unusual depressed/anxious mood, stomach/muscle cramps, vomiting, sweating, shakiness, seizures) may occur if you suddenly stop using this medication.

Our Restoril (temazepam) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Restoril Consumer Information

Temazepam may cause a severe allergic reaction. Stop taking temazepam and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using temazepam and call your doctor at once if you have any of these serious side effects:

  • weak or shallow breathing;
  • fast or pounding heartbeats;
  • confusion, slurred speech, unusual thoughts or behavior;
  • hallucinations, agitation, aggression;
  • thoughts of suicide or hurting yourself;
  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • pale skin, easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms;
  • problems with urination; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • daytime drowsiness (or during hours when you are not normally sleeping);
  • amnesia or forgetfulness;
  • muscle weakness, lack of balance or coordination;
  • numbness, burning, pain, or tingly feeling;
  • headache, blurred vision, depressed mood;
  • feeling nervous, excited, or irritable;
  • nausea, vomiting, stomach discomfort; or
  • dry mouth, increased thirst.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Restoril (Temazepam)

Restoril Professional Information

SIDE EFFECTS

During controlled clinical studies in which 1076 patients received Restoril 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:

  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 including restlessness, overstimulation and agitation were rare (less than 0.5%).

Drug Abuse And Dependence

Abuse and addiction are separate and distinct 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 that is 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 in which exposure to a drug induces changes that result in a diminution of one or more of the drug's effects over time. Tolerance may occur to both the desired and undesired effects of drugs and may develop at different rates for different effects.

Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.

Controlled Substance

Restoril is a controlled substance in Schedule IV.

Abuse And Dependence

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal, and muscle cramps, vomiting, and sweating), have occurred following abrupt discontinuance of benzodiazepines. The more severe withdrawal symptoms have usually been limited to those patients who received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy at doses higher than 15 mg, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. As with any hypnotic, caution must be exercised in administering Restoril to individuals known to be addiction-prone or to those whose history suggests they may increase the dosage on their own initiative. It is desirable to limit repeated prescriptions without adequate medical supervision.

Read the entire FDA prescribing information for Restoril (Temazepam)

Related Resources for Restoril

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