Restoril

What Is Restoril?

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.

What Are Side Effects of Restoril?

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).

Dosage for Restoril

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.

What Drugs, Substances, or Supplements Interact with Restoril?

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 During Pregnancy and Breastfeeding

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.

Additional Information

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

 

Restoril Consumer Information

Temazepam may cause a severe allergic reaction. Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; nausea, vomiting; swelling of your face, lips, tongue, or throat.

Temazepam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. A person caring for you should seek emergency medical attention if you have weak or shallow breathing, if you are hard to wake up, or if you stop breathing.

Call your doctor at once if you have:

• confusion, agitation, hallucinations;
• depressed mood; or
• thoughts of suicide or hurting yourself.

Some people using temazepam have engaged in activity such as driving, eating, making phone calls, or having sex and later having no memory of the activity. Tell your doctor if this happens to you.

The sedative effects of temazepam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines.

Common side effects may include:

• day-time drowsiness or "hangover" feeling;
• headache;
• dizziness, tiredness;
• nausea; or
• feeling nervous.

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.

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%).

Read the entire FDA prescribing information for Restoril (Temazepam)