Flurazepam

MEDICATION GUIDE

Dalmane (flurazepam) ®
(DAL-main) Capsules, 15 mg and 30 mg

is a Sedative-Hypnotic indicated for Insomnia

Generic name: flurazepam (flew-raz-e-pam) hydrochloride capsules

Read this Medication Guide carefully before you start taking your medicine and each time you get more, since there may be new information. It does not contain all the information about your medicine that you may need to know, so please ask your doctor, nurse or pharmacist if you have any questions.

IMPORTANT

YOUR DOCTOR HAS PRESCRIBED THIS DRUG FOR YOUR USE ONLY. DO NOT LET ANYONE ELSE USE IT. KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN AND PETS. If a child puts a Dalmane® (flurazepam) capsule in his or her mouth or swallows it, call your local Poison Control Center or go immediately to the nearest emergency room.

What is the most important information I should know about sedative-hypnotic drugs?

After taking a sedative-hypnotic drug, 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 medications that make you sleepy with a sedative-hypnotic drug.

Reported activities include:

• driving a car ("sleep-driving")
• making and eating food
• talking on the phone
• having sex
• sleep-walking

Important:

1. Take a sedative-hypnotic drug exactly as prescribed:
   • Do not take more sedative-hypnotic drugs than prescribed.
   • Take the sedative-hypnotic drug right before you get in bed, not sooner.
2. Do not take a sedative-hypnotic drug if you:
   • drink alcohol
   • take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take a sedative-hypnotic drug with your other medicines
   • cannot get a full night sleep
3. Call your doctor right away if you find out that you have done any of the above activities after taking a sedative-hypnotic drug.

What is Dalmane® (flurazepam) ?

Dalmane® (flurazepam) is a sedative-hypnotic agent used to treat insomnia (difficulty falling asleep and staying asleep).

Who should not take Dalmane® (flurazepam) ?

Do not use Dalmane® (flurazepam) if you are:

• allergic to anything in Dalmane® (flurazepam) . (Being allergic may include having a rash, itching, swelling or breathing difficulties.) See the end of this Medication Guide for a complete list of ingredients in Dalmane® (flurazepam) . In rare cases patient have had additional symptoms such as shortness of breath, throat closing, or nausea and vomiting that suggest an allergic reaction. Some patients have required medical therapy in the emergency department as these rare complications could be fatal. Patients who experience these symptoms should seek medical attention and discontinue taking the sedative-hypnotic drug.
• pregnant or intending to become pregnant. If a woman becomes pregnant while taking Dalmane® (flurazepam) , she should discontinue use immediately.
• under 15 years of age. Dalmane® (flurazepam) has not been studied in children.

How should I take Dalmane® (flurazepam) ?

Dalmane® (flurazepam) comes as a capsule to take by mouth. You should take Dalmane® (flurazepam) , or other sedative-hypnotic medications, exactly as directed by your doctor. It usually is taken right before you get in bed, not sooner. If you forget to take Dalmane® (flurazepam) at bedtime, you are unable to fall asleep, and you will still be able to stay in bed for a full night's sleep, you may take Dalmane® (flurazepam) at that time. Do not take a double dose of Dalmane® (flurazepam) to make up for a missed dose.

The smallest possible effective dose is suggested for elderly patients due to the risk of the development of oversedation, dizziness, confusion and/or loss of coordination.

Sleep problems are often temporary, requiring treatment for a very short time. You should not use Dalmane® (flurazepam) , or any other sedative-hypnotic medications, for long periods of time without talking to your doctor about the risks and benefits of prolonged use.

In the case of a suspected overdose, you should contact your local poison control center immediately.

What should I avoid while taking Dalmane® (flurazepam) ?

Do not drink alcohol or take other medications that depress the central nervous system.

While taking Dalmane® (flurazepam) , do not engage in any hazardous occupations requiring complete mental alertness such as operating machinery or driving a car.

What are the possible or reasonably likely side effects of Dalmane® (flurazepam) ?

Dizziness, drowsiness, light-headedness, staggering, loss of coordination and falling have occurred, particularly in elderly or debilitated persons. Severe sedation, lethargy, disorientation and coma, probably indicative of drug intolerance or overdosage, have been reported. Also reported are headache, heartburn, upset stomach, nausea, vomiting, diarrhea, constipation, nervousness, talking more than usual, anxiety, irritability, weakness, pounding heartbeat, chest pain, body and joint pains and difficulty urinating.

General information about the safe and effective use of Dalmane® (flurazepam)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you have any concerns about taking this, or any sedative-hypnotic medication, please ask your doctor. For detailed information regarding Dalmane® (flurazepam) please consult the physician's package insert. Do not use for conditions for which this medication was not prescribed. Do not give this medication to others.

What are the ingredients of Dalmane (flurazepam) ® Capsules?

Active Ingredient: flurazepam hydrochloride (15 mg or 30 mg)
Inactive Ingredients: Each 15 mg capsule also contains cornstarch, lactose, magnesium stearate and talc; gelatin capsule shells contain D&C Red No. 28, FD&C Red No. 40, FD&C Yellow No. 6 and D&C Yellow No. 10. Each 30 mg capsule also contains cornstarch, lactose and magnesium stearate; gelatin capsule shells contain FD&C Blue No. 1, FD&C Yellow No. 6, D&C Yellow No. 10 and either FD&C Red No. 3 or FD&C Red No. 40.

How should I store Dalmane® (flurazepam) Capsules?

• Store Dalmane® (flurazepam) Capsules at 25°C (77°F); excursions permitted to 15°C -30°C (59°F - 86°F) [see USP Controlled Room Temperature].
• KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN. If a child accidentally takes Dalmane® (flurazepam) , call your local Poison Control Center or go immediately to the nearest emergency room.

This Medication Guide has been approved by the U.S. Food and Drug Administration.
Distributed by: Valeant Pharmaceuticals North America Aliso Viejo, CA 92625 U.S.A. Rev. Date: 3/09

Flurazepam may be found in some form under the following brand names:

• Dalmane

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of flurazepam, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking flurazepam, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to flurazepam or to any of its ingredients
• have ever drunk large amounts of alcohol
• have ever used street drugs or have overused prescription drugs
• have or have had depression or mental illness
• have sleep apnea
• have lung disease
• have kidney disease
• have liver disease

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

• Benzodiazepines
• Insomnia (Symptoms, Causes, Remedies, and Cures)
• Insomnia Treatment (Sleep Aids and Stimulants)
• Prescription Anxiety Medications
• Sleep Disorder Drugs
• Sleep Disorders (How to Get a Good Night's Sleep)

Flurazepam is a benzodiazepine (ben-zoe-dye-AZE-eh-peen) similar to Valium. Flurazepam affects chemicals in the brain that may be unbalanced in people with sleep problems (insomnia).

Flurazepam is used to treat symptoms of insomnia, such as trouble falling or staying asleep.

Flurazepam may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Flurazepam may be habit forming. Never share flurazepam with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

Take flurazepam only if you are able to get a full night's sleep before you must be active again. Never take this medicine during your normal waking hours, unless you have at least 7 to 8 hours to dedicate to sleeping.

Call your doctor if your insomnia does not improve after taking flurazepam for 7 to 10 nights, or if you have any mood or behavior changes. Insomnia can be a symptom of depression, mental illness, or certain medical conditions.

Do not stop using flurazepam suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using flurazepam.

Your insomnia symptoms may return when you stop using flurazepam after using it over a long period of time. You may need to use less and less before you stop the medication completely.

Store at room temperature away from moisture, heat, and light.

Keep track of the amount of medicine used from each new bottle. Flurazepam is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about flurazepam, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about flurazepam. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using flurazepam.

Review Date: October 4, 2017

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Available human data on the risk of teratogenicity for benzodiazepines are inconclusive. There is insufficient evidence in humans to assess the effect of benzodiazepine exposure during pregnancy or neurodevelopment. Administration of benzodiazepines immediately prior to or during childbirth can result in a syndrome of hypothermia, hypotonia, respiratory depression, and difficulty feeding. In addition, infants born to mothers who have taken benzodiazepines during the later stages of pregnancy can develop dependence, and subsequently withdrawal, during the postnatal period. Administration of Flurazepam to pregnant animals did not indicate a risk for adverse effects on morphological development at clinically relevant doses; however, animal data for other benzodiazepines suggest that possibility of adverse developmental effects (including long-term effects on neurobehavioral and immunological function) following prenatal exposure. Flurazepam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pregnancy Registry

To provide information regarding the effects of in utero exposure to Flurazepam, physicians are advised to recommend that pregnant patients taking Flurazepam enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves or their caregiver. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Flurazepam may cause confusion and over-sedation in the elderly. Elderly patients generally should be started on a low dose of Flurazepam and observed closely.

Elderly or debilitated patients may be more sensitive to benzodiazepines, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Flurazepam hydrochloride is chemically 7-chloro-1-[2-(diethylamino)ethyl]-5-(o-fluoro-phenyl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one dihydrochloride. It is a pale yellow, crystalline compound, freely soluble in alcohol and very soluble in water. It has a molecular weight of 460.81 and the following structural formula:

Each capsule for oral administration contains either 15 mg or 30 mg of Flurazepam hydrochloride, USP and the following inactive ingredients: colloidal silicon dioxide, FD&C Blue No. 1, FD&C Red No. 3, gelatin, magnesium stearate, microcrystalline cellulose, powdered cellulose, sodium lauryl sulfate and titanium dioxide. The imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.

NDC 0378-4415-01

Flurazepam
Hydrochloride
Capsules, USP
CIV
15 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only 100 Capsules

Each capsule contains:
Flurazepam
hydrochloride, USP 15 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F ).
[See USP Controlled Room
Temperature.]

Protect from light.

Usual Adult Dosage: See
accompanying prescribing
information.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Mylan.com

RM4415A10

(flure AZ e pam)

• Hypnotic, Benzodiazepine

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Monitor therapy

Analgesics (Opioid): CNS Depressants may enhance the CNS depressant effect of Analgesics (Opioid). Management: Avoid concomitant use of opioid analgesics and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Aprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Avoid combination

Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Consider therapy modification

Bosentan: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine patches (Butrans brand) at 5 mcg/hr in adults when used with other CNS depressants. Consider therapy modification

Cannabis: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Consider therapy modification

Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy

CloZAPine: Benzodiazepines may enhance the adverse/toxic effect of CloZAPine. Management: Consider decreasing the dose of (or possibly discontinuing) benzodiazepines prior to initiating clozapine. Consider therapy modification

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Monitor therapy

Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Avoid combination

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Monitor therapy

CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates. Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates. Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Dasatinib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Monitor therapy

Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (e.g., opioids, barbiturates) with concomitant use. Consider therapy modification

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates. Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Consider therapy modification

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Consider therapy modification

Fosamprenavir: May increase the serum concentration of Flurazepam. Monitor therapy

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates. Avoid combination

HYDROcodone: CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Avoid concomitant use of hydrocodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Idelalisib: May increase the serum concentration of CYP3A4 Substrates. Avoid combination

Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Melatonin: May enhance the sedative effect of Benzodiazepines. Monitor therapy

Methadone: Benzodiazepines may enhance the CNS depressant effect of Methadone. Avoid combination

Methotrimeprazine: May enhance the CNS depressant effect of CNS Depressants. CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Consider therapy modification

MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Monitor therapy

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates. Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Consider therapy modification

Minocycline: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Mirtazapine: CNS Depressants may enhance the CNS depressant effect of Mirtazapine. Monitor therapy

Mitotane: May decrease the serum concentration of CYP3A4 Substrates. Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Consider therapy modification

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Netupitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

OLANZapine: May enhance the adverse/toxic effect of Benzodiazepines. Management: Avoid concomitant use of parenteral benzodiazepines and IM olanzapine due to risks of additive adverse events (e.g., cardiorespiratory depression). Olanzapine prescribing information provides no specific recommendations regarding oral administration. Avoid combination

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Avoid combination

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Avoid combination

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Palbociclib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Avoid combination

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Consider therapy modification

Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Monitor therapy

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Monitor therapy

Ritonavir: May increase the serum concentration of Flurazepam. Monitor therapy

ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Monitor therapy

Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Monitor therapy

Saquinavir: May increase the serum concentration of Flurazepam. Monitor therapy

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Sodium Oxybate: Benzodiazepines may enhance the CNS depressant effect of Sodium Oxybate. Avoid combination

St John's Wort: May decrease the serum concentration of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

Stiripentol: May increase the serum concentration of CYP3A4 Substrates. Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Consider therapy modification

Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Teduglutide: May increase the serum concentration of Benzodiazepines. Monitor therapy

Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Avoid combination

Theophylline Derivatives: May diminish the therapeutic effect of Benzodiazepines. Consider therapy modification

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Yohimbine: May diminish the therapeutic effect of Antianxiety Agents. Monitor therapy

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Consider therapy modification

Frequency not defined.

Cardiovascular: Chest pain, flushing, hypotension, palpitations, syncope

Central nervous system: Abnormal reflexes (slowing), apprehension, ataxia, bitter taste, body pain, confusion, depression, dizziness, drowsiness, drug dependence, dysarthria, euphoria, falling, hallucination, hangover effect, headache, irritability, memory impairment, nervousness, paradoxical reaction, restlessness, slurred speech, staggering, talkativeness

Dermatologic: Diaphoresis, pruritus, skin rash

Endocrine & metabolic: Weight gain, weight loss

Gastrointestinal: Constipation, decreased appetite, diarrhea, gastric distress, gastrointestinal pain, heartburn, increased appetite, nausea, sialorrhea, vomiting, xerostomia

Hematologic & oncologic: Granulocytopenia, leukopenia

Hepatic: Abnormal bilirubin levels (total bilirubin increased), cholestatic jaundice, increased serum alkaline phosphatase, increased serum ALT, increased serum AST

Neuromuscular & skeletal: Arthralgia, weakness

Ophthalmic: Accommodation disturbance, blurred vision, burning sensation of eyes

Respiratory: Apnea, dyspnea

<1% (Limited to important or life-threatening): Anaphylaxis, angioedema, parasomnias (cooking while sleeping, making phone calls while sleeping, sleep driving, sleep eating)