Restoril

Primary Uses

Restoril is primarily prescribed to treat insomnia. It belongs to a class of drugs known as benzodiazepines, which work by slowing activity in the brain to facilitate sleep. It is typically used to address various sleep challenges, including:

• Difficulty falling asleep at the beginning of the night.
• Frequent or prolonged waking during the night.
• Waking up too early in the morning.

Short-Term Treatment

This medication is intended for short-term use, generally for a period of 7 to 10 days. It is often used when sleep disturbances interfere with daily functioning or cause significant distress. Because it is a short-term solution, healthcare providers usually re-evaluate the need for the medication if sleep problems persist beyond a few weeks.

Mechanism of Action

Restoril (temazepam) is a central nervous system depressant. It works by affecting certain natural chemicals in the brain to produce a calming effect. Specifically, it enhances the activity of gamma-aminobutyric acid (GABA), a neurotransmitter that inhibits or slows down signals in the nervous system.

By increasing the effects of GABA, Restoril helps to relax the body and mind. This process helps manage insomnia by:

• Reducing the time it takes to fall asleep.
• Decreasing the number of times a person wakes up during the night.
• Increasing the total amount of time spent sleeping.

Because the medication slows down brain activity, it induces drowsiness and relaxation, making it easier for the body to transition into a restful state.

Common Side Effects

Restoril may cause side effects that are usually mild. Tell your doctor if any of these symptoms are severe or do not go away:

• Daytime drowsiness or sleepiness
• Dizziness or lightheadedness
• Headache
• Nausea or upset stomach
• Nervousness
• Fatigue or tiredness
• Dry mouth
• Diarrhea

Serious Side Effects

Some side effects can be serious. If you experience any of the following, call your doctor immediately or seek emergency medical treatment:

• Signs of an allergic reaction, such as rash, hives, or swelling of the face, throat, tongue, or lips
• Difficulty breathing or swallowing
• Hoarseness
• Blurred vision or other vision changes
• Severe coordination problems or feeling unsteady
• Confusion, hallucinations, or unusual changes in mood or behavior
• New or worsening depression or suicidal thoughts
• Memory loss or forgetfulness

Complex Sleep Behaviors

In some cases, people taking Restoril have gotten out of bed and performed activities while not fully awake. These individuals often have no memory of the event. Contact your healthcare provider immediately if you learn you have done any of the following:

• Sleep-driving (driving while not fully awake)
• Preparing and eating food
• Making phone calls
• Having sexual relations
• Sleep-walking

Boxed Warnings

Restoril (temazepam) has boxed warnings for the following risks:

• Risks from Concomitant Use with Opioids: Using benzodiazepines with opioid medications may result in profound sedation, respiratory depression, coma, and death. Combined use is reserved for patients for whom alternative treatment options are inadequate.
• Abuse, Misuse, and Addiction: The use of benzodiazepines, including Restoril, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death.
• Physical Dependence and Withdrawal Reactions: Continued use may lead to physical dependence. Abruptly stopping or reducing the dosage rapidly can cause life-threatening withdrawal reactions.

Complex Sleep Behaviors

Restoril can cause serious side effects called complex sleep behaviors. These involve getting out of bed while not being fully awake and doing activities that the person does not know they are doing. These activities may include sleep-walking, sleep-driving, preparing and eating food, making phone calls, or having sexual intercourse. Some of these events have resulted in serious injuries or death.

Central Nervous System (CNS) Depression

Because Restoril causes drowsiness and decreased awareness, it can impair the ability to perform tasks that require mental alertness, such as driving or operating machinery. This effect may persist into the day after taking the medication. Alcohol and other CNS depressants can increase these effects.

Severe Allergic Reactions

Rare but serious allergic reactions, including anaphylaxis and angioedema (swelling of the tongue, glottis, or larynx), have been reported. These reactions can occur as early as the first dose and may be life-threatening.

Worsening of Depression

In patients with primary depression, benzodiazepines may worsen the condition or lead to suicidal thoughts and actions. Caution is used when prescribing this medication to individuals with signs of depression.

Pregnancy and Nursing

Restoril may cause fetal harm when administered to pregnant women. It is generally avoided during pregnancy. Because the drug may pass into breast milk, its use is typically not recommended for those who are breastfeeding.

Pregnancy

Restoril belongs to a class of medications known as benzodiazepines. Using this medication during pregnancy may increase the risk of birth defects, especially if taken during the first trimester. If used during the later stages of pregnancy, the baby may experience withdrawal symptoms after birth. These symptoms can include:

• Irritability or excessive crying
• Tremors or muscle shakiness
• Difficulty breathing
• Feeding problems
• Muscle weakness, sometimes referred to as floppy infant syndrome

If you are pregnant or planning to become pregnant, discuss the risks and benefits of this medication with your healthcare provider. It is important not to stop taking the medication suddenly without medical guidance, as this can cause withdrawal symptoms in the parent.

Breastfeeding

Restoril passes into breast milk and can affect a nursing infant. Babies exposed to the medication through breast milk may experience excessive sleepiness, lethargy, or difficulty feeding. Because of these potential risks, healthcare providers generally advise caution or suggest alternative treatments while breastfeeding. Consult with a clinician to determine the safest approach for you and your child.

Available Forms

Restoril is supplied in the following form for oral administration:

• Oral Capsule

The medication is intended to be swallowed whole and is typically used for short periods to help with sleep onset or maintenance.

FDA Approval and Indications

Restoril (temazepam) is approved by the U.S. Food and Drug Administration (FDA) for the short-term treatment of insomnia, generally defined as 7 to 10 days of use. It is intended for patients who have difficulty falling asleep or staying asleep.

Boxed Warnings

The FDA requires a boxed warning—its most serious type of warning—for Restoril due to several significant risks:

• Risks from Concomitant Use with Opioids: Using benzodiazepines like Restoril alongside opioid medications may result in profound sedation, respiratory depression, coma, and death. Combined use should be reserved for patients for whom alternative treatment options are inadequate.
• Abuse, Misuse, and Addiction: The use of benzodiazepines exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing, healthcare providers should assess each patient's risk.
• Physical Dependence and Withdrawal Reactions: Continued use of Restoril can lead to physical dependence. Abruptly stopping the medication or reducing the dosage too quickly can cause life-threatening withdrawal reactions, such as seizures.

Controlled Substance Status

Restoril is classified as a Schedule IV controlled substance under the Controlled Substances Act. This classification is due to its potential for abuse and the risk of developing physical or psychological dependence.

Withdrawal Symptoms

If you have been taking Restoril regularly, stopping the medication abruptly can lead to withdrawal. Symptoms may begin within a few hours to several days after the last dose and can include:

• Convulsions or seizures
• Tremors or shaking
• Abdominal and muscle cramps
• Vomiting and nausea
• Sweating
• Severe insomnia
• Anxiety and agitation
• Hallucinations
• Depression

In some cases, withdrawal symptoms can be severe or life-threatening. Seizures are a significant risk for those who have taken high doses over a long period.

Managing Withdrawal

To avoid or minimize withdrawal symptoms, doctors typically recommend a gradual reduction in dosage, known as tapering. Do not stop taking Restoril or change your dose without consulting your healthcare provider first. They will create a schedule to slowly lower the amount of medication your body receives.

Physical dependence can occur even if the medication is taken exactly as prescribed. If you experience unusual changes in mood, suicidal thoughts, or physical distress while lowering your dose, contact your doctor immediately.