MEDICATION GUIDE

MEDICATION GUIDE
TEMAZEPAM ( tem az’ e pam) Capsules, C-IV

What is the most important information I should know about
temazepam?
• temazepam is a benzodiazepine medicine. Taking
benzodiazepines with opioid medicines, alcohol, or other central
nervous system (CNS) depressants (including street drugs) can
cause severe drowsiness, breathing problems (respiratory
depression), coma and death. Get emergency help right away if any
of the following happens:
° shallow or slowed breathing
° breathing stops (which may lead to the heart stopping)
° excessive sleepiness (sedation)

Do not drive or operate heavy machinery until you know how taking
temazepam and opioids affects you.
° Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with benzodiazepines including temazepam
which can lead to overdose and serious side effects including
coma and death. Serious side effects including coma and death
have happened in people who have abused or misused
benzodiazepines, including temazepam. These serious side
effects may also include delirium, paranoia, suicidal thoughts or
actions, seizures, and difficulty breathing. Call your healthcare
provider or go to the nearest hospital emergency room right
away if you get any of these serious side effects.
° You can develop an addiction even if you take temazepam as
prescribed by your healthcare provider
° Take temazepam exactly as your healthcare provider
prescribed.
° Do not share your temazepam with other people.
° Keep temazepam in a safe place and away from children.

• Physical dependence and withdrawal reactions. temazepam can
cause physical dependence and withdrawal reactions.
° Do not suddenly stop taking temazepam. Stopping temazepam
suddenly can cause serious and life-threatening side effects,
including, unusual movements, responses, or expressions,
seizures, sudden and severe mental or nervous system changes,
depression, seeing or hearing things that others do not see or hear,
an extreme increase in activity or talking, losing touch with reality,
and suicidal thoughts or actions. Call your healthcare provider or
go to the nearest hospital emergency room right away if you
get any of these symptoms.
° Some people who suddenly stop benzodiazepines have
symptoms that can last for several weeks to more than
12 months , including, anxiety, trouble remembering, learning, or
concentrating, depression, problems sleeping, feeling like insects
are crawling under your skin, weakness, shaking, muscle
twitching, burning or prickling feeling in your hands, arms, legs or
feet, and ringing in your ears.
° Physical dependence is not the same as drug addiction. Your
healthcare provider can tell you more about the differences
between physical dependence and drug addiction.
° Do not take more temazepam than prescribed or take temazepam
for longer than prescribed.

• After taking temazepam, you may get up out of bed while not being
fully awake and do an activity that you do not know you are doing. The
next morning, you may not remember that you did anything during the
night. You have a higher chance for doing these activities if you drink
alcohol or take other medicines that make you sleepy with
temazepam. Reported activities include:
° driving a car (“sleep driving”)
° making and eating food
° talking on the phone
° having sex
° sleep-walking
Call your healthcare provider right away if you find out that you have
done any of the above activities after taking temazepam.

What is temazepam?
• Temazepam is a prescription sleep medicine. Temazepam is used in
adults for the short-term (usually 7 to 10 days) treatment of a sleep
problem called insomnia. Symptoms of insomnia include trouble falling
asleep and waking up often during the night.
• Temazepam is a federal controlled substance (C-IV) because it
can be abused or lead to dependence. Keep temazepam in a safe
place to prevent misuse and abuse. Selling or giving away temazepam
may harm others, and is against the law. Tell your healthcare provider
if you have ever abused or been dependent on alcohol, prescription
medicines or street drugs.
• It is not known if temazepam is safe and effective in children.
• It is not known if temazepam is safe and effective for use longer than
2 weeks

Do not take temazepam if you:
• are allergic to temazepam or any of the ingredients in temazepam
capsules. See the end of this Medication Guide for a complete list of
ingredients in temazepam capsules.

Before you take temazepam, tell your healthcare provider about all of
your medical conditions, including if you:
• have a history of depression, mental illness or, suicidal thoughts
• have a history of drug or alcohol abuse or addiction
• have lung disease or breathing problems
• are pregnant or plan to become pregnant. Temazepam may cause birth
defects or harm your unborn baby.
• are breastfeeding, or plan to breastfeed. Temazepam may pass
through your breast milk and may harm your baby. Talk to your
healthcare provider about the best way to feed your baby if you take
temazepam.

Tell your healthcare provider about all of the medicines you take,
including prescription and over-the-counter medicines, vitamins, and
herbal supplements.

Taking temazepam with certain other medicines can cause side effects or
affect how well temazepam or the other medicines work. Do not start or
stop other medicines without talking to your healthcare provider.
Do not take temazepam with other medicines that can make you sleepy
unless your healthcare provider tells you to.
How should I take temazepam?
• See “What is the most important information I should know about
temazepam?”
• Take temazepam exactly as your healthcare providers tell you to take
it. Take temazepam right before you get into bed.
• Do not take temazepam unless you are able to get a full night’s sleep
before you must be active again.
• If you take too much temazepam or overdose, get emergency
treatment right away.

What are the possible side effects of temazepam?
Temazepam may cause serious side effects, including:
• See “What is the most important information I should know about
temazepam?”
• Abnormal thoughts and behavior. Symptoms include more outgoing
or aggressive behavior than normal, confusion, agitation,
hallucinations, worsening of depression, and suicidal thoughts.
• Severe allergic reactions. Symptoms include swelling of the tongue
or throat, trouble breathing, and nausea and vomiting. Get emergency
medical help right away if you have these symptoms after taking
temazepam.
Temazepam can make you sleepy or dizzy and can slow your thinking
and motor skills.
° Do not drive, operate heavy machinery, or do other dangerous
activities until you know how temazepam affects you.
° Do not drink alcohol or take other drugs that may make you
sleepy or dizzy while taking temazepam talking to your
healthcare provider . When taken with alcohol or other drugs that
cause sleepiness or dizziness, temazepam may make your
sleepiness or dizziness much worse.

The most common side effects of temazepam include:
• drowsiness
• headache
• tiredness
• nervousness
• dizziness
• nausea
You may still feel drowsy the next day after taking temazepam. Do not
drive or do other dangerous activities after taking temazepam until
you feel fully awake.
These are not all the possible side effects of temazepam. Call your doctor
for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.

How should I store temazepam?
• Store temazepam at room temperature between 68°F to 77°F (20°C to
25°C).
• Keep temazepam and all medicines out of the reach of children.
General information about the safe and effective use of temazepam.
Medicines are sometimes prescribed for purposes other than those listed
in a Medication Guide. Do not use temazepam for a condition for which it
was not prescribed. Do not give temazepam to other people, even if they
have the same symptoms that you have. It may harm them. You can ask
your healthcare provider or pharmacist for information about temazepam
that is written for healthcare professionals.

What are the ingredients in temazepam?

7.5mg Capsules
Active Ingredient: temazepam USP

7.5 mg Capsules
Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate,
sodium lauryl sulfate, FD&C Red #40 and titanium dioxide.

May also include: sodium lauryl sulfate. Imprinting ink may contain
ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac,
potassium hydroxide, propylene glycol, and black iron oxide.

If you would like more information, call Novel Laboratories, Inc. at
1-866-403-7592

This Medication Guide has been approved by the U.S. Food and Drug
Administration

Manufactured by:
Novel Laboratories, Inc
Somerset, NJ 08873

Distributed by:
McKesson Corporation dba SKY Packaging
Memphis, TN 38141

Rev. 04/2022

21359-1