Restoril (Temazepam) | Pharmaceutical Product Information

Product Description

Restoril is a prescription medication containing temazepam, a benzodiazepine sedative-hypnotic used primarily for the short-term management of insomnia. It may help patients who experience difficulty falling asleep or maintaining sleep.

Temazepam enhances the activity of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter in the central nervous system. This produces sedative and sleep-promoting effects but can also cause impaired alertness, memory problems, dependence, withdrawal symptoms, and respiratory depression.

Restoril should be used only under the supervision of a qualified healthcare professional and according to the official prescribing information.

What Is Restoril?

Restoril is a brand name for temazepam, a benzodiazepine hypnotic medication. It is generally intended for short-term use in patients with clinically significant insomnia.

It may be prescribed for sleep difficulties involving:

• Difficulty falling asleep

• Frequent nighttime awakenings

• Difficulty maintaining sleep

• Sleep disruption associated with certain clinical conditions

The suitability of temazepam depends on the patient’s medical history, age, other medicines, and risk of dependence or respiratory complications.

Key Product Information

Mechanism of Action

Temazepam enhances the effects of GABA at the GABA-A receptor complex. GABA reduces excessive activity in the central nervous system, resulting in sedative, anxiolytic, and sleep-promoting effects.

The effects of temazepam may include:

• Reduced time required to fall asleep

• Reduced nighttime awakenings

• Increased sleep continuity

• Reduced central nervous system activity

• Impaired alertness and coordination

The response varies between individuals, and the medication should be regularly reviewed by the prescribing clinician.

Medical Uses

1. Insomnia

Restoril is used for the short-term management of insomnia when sleep difficulties are clinically significant.

Symptoms may include:

• Difficulty initiating sleep

• Difficulty maintaining sleep

• Repeated nighttime awakenings

• Sleep disruption affecting daily activities

A healthcare professional should evaluate persistent insomnia for underlying causes and consider non-medication treatments where appropriate.

2. Short-Term Sleep Treatment

Temazepam is generally intended for short-term use because regular or prolonged use may increase the risk of tolerance, dependence, and withdrawal.

Treatment duration should be based on clinical assessment and the official product information.

Potential Benefits

When appropriately prescribed, Restoril may help:

• Reduce the time needed to fall asleep

• Support sleep continuity

• Reduce nighttime awakenings

• Improve sleep duration in some patients

• Provide short-term relief from insomnia symptoms

Restoril does not necessarily treat the underlying cause of chronic insomnia. Behavioral treatment, sleep-hygiene strategies, and cognitive behavioral therapy for insomnia may also be considered.

Dosage and Administration

The appropriate dose depends on:

• Age

• Overall health

• Liver and kidney function

• Other medications

• Previous exposure to sedatives

• Individual response

• Risk of next-day impairment

The dose must be determined by a healthcare professional. Temazepam should be taken exactly as prescribed and generally only when the patient can remain in bed for a full night.

Important Administration Precautions

• Take only the prescribed amount.

• Take the medicine shortly before going to bed.

• Ensure sufficient time remains for a full night of sleep.

• Do not take an additional dose during the same night unless specifically directed.

• Do not combine with alcohol, opioids, or other sedative medicines unless explicitly instructed and monitored by a clinician.

• Do not drive or operate machinery while affected.

• Do not stop regular treatment suddenly without medical advice.

The exact administration instructions should be confirmed through the medicine’s official leaflet.

Common Side Effects

Possible side effects of temazepam include:

• Drowsiness

• Dizziness

• Fatigue

• Headache

• Muscle weakness

• Impaired coordination

• Reduced alertness

• Confusion

• Memory difficulties

• Slurred speech

• Nausea

• Next-day sleepiness

Older adults may be more vulnerable to falls, confusion, and impaired balance.

Serious Warnings and Risks

1. Respiratory Depression

Temazepam may suppress breathing, especially when combined with:

• Opioids

• Alcohol

• Other benzodiazepines

• Sleeping medicines

• Sedating antihistamines

• Other central nervous system depressants

Extreme sleepiness, slow or difficult breathing, inability to wake, or loss of consciousness requires emergency medical assistance.

2. Dependence and Withdrawal

Benzodiazepines can cause physical dependence, even when taken as prescribed. Risk may increase with prolonged treatment, higher doses, or misuse.

Withdrawal symptoms may include:

• Anxiety

• Irritability

• Insomnia

• Tremors

• Sweating

• Agitation

• Sensory disturbances

• Seizures

• Severe confusion or delirium

A clinician may recommend a gradual, individualized dose reduction when discontinuing regular treatment.

3. Impaired Driving and Coordination

Restoril can impair reaction time, judgment, memory, and coordination. Patients should avoid driving and hazardous activities until they know how the medication affects them.

4. Abnormal Behavioral Reactions

Some individuals may experience paradoxical reactions, such as:

• Agitation

• Irritability

• Aggression

• Restlessness

• Increased anxiety

• Unusual behavior

Contact a healthcare professional if significant behavioral changes occur.

5. Suicidal Thoughts and Mental Health Symptoms

Sedative medicines may require additional caution in people with depression or other mental health conditions. Report new or worsening mood changes, unusual behavior, or suicidal thoughts immediately.

Drug Interactions

Inform your healthcare professional about all prescription medicines, over-the-counter products, and supplements.

Contraindications and Precautions

Restoril may not be appropriate for everyone. Inform your healthcare professional if you have:

• Severe respiratory disease

• Sleep apnea

• Severe liver impairment

• A history of substance misuse or dependence

• Depression or other mental health conditions

• A history of suicidal thoughts or behavior

• Myasthenia gravis

• Pregnancy or plans to become pregnant

• Breastfeeding

• Allergies to temazepam or other benzodiazepines

Older adults may require additional caution because of the increased risk of falls, confusion, and prolonged sedation.

Storage Information

Store Restoril according to the official product label and pharmacy instructions.

General precautions include:

• Keep the medicine in its original packaging.

• Store it away from excessive heat and moisture.

• Keep it out of reach of children.

• Do not use expired medicine.

• Do not share prescription medication.

• Dispose of unused medicine through an approved disposal service.

Storage requirements may vary by formulation and jurisdiction.

Frequently Asked Questions

What is Restoril used for?

Restoril contains temazepam and is primarily prescribed for the short-term treatment of insomnia involving difficulty falling asleep or maintaining sleep.

Is Restoril a benzodiazepine?

Yes. Temazepam is a benzodiazepine sedative-hypnotic that enhances GABA-related inhibitory activity in the central nervous system.

Can Restoril cause dependence?

Yes. Temazepam can cause tolerance, physical dependence, and misuse-related problems. The risk increases with prolonged use or use outside medical supervision.

Can Restoril be taken with alcohol?

No. Combining temazepam with alcohol can increase sedation, impair coordination, suppress breathing, and potentially cause life-threatening complications.

Can Restoril be taken with opioids?

Combining temazepam with opioids increases the risk of severe sedation, respiratory depression, coma, and death. The combination should only be used when specifically justified and closely monitored by a healthcare professional.

Can Restoril be used every night?

The appropriate duration depends on the patient’s clinical circumstances. Because of dependence and tolerance risks, regular use should be reviewed by a healthcare professional.

Does Restoril cause next-day drowsiness?

Yes. Temazepam may cause next-day sedation, impaired coordination, and reduced alertness, especially in older adults or when combined with other sedatives.

Should Restoril be stopped suddenly?

Do not stop regular or prolonged treatment suddenly without medical guidance. Abrupt discontinuation may cause withdrawal symptoms, including seizures in severe cases.