Rozerem

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

GENERIC AVAILABLE: No.

Oral Administration

Take within 30 min of going to bed

Do not take with or immediately after high fat meal

Dosage Forms And Strengths

ROZEREM (ramelteon) is available in an 8 mg strength tablet for oral administration.

ROZEREM (ramelteon) 8 mg tablets are round, pale orange-yellow, film-coated, with “TAK” and “RAM-8” printed on one side.

Storage And Handling

ROZEREM (ramelteon) is available as round, pale orange-yellow, film-coated, 8 mg tablets, with “TAK” and “RAM-8” printed on one side, in the following quantities:

NDC 64764-805-30 Bottles of 30
NDC 64764-805-10 Bottles of 100
NDC 64764-805-50 Bottles of 500

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP controlled room temperature]. Keep container tightly closed and protected from moisture and humidity.

Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Revised: 11/10

MEDICATION GUIDE

ROZEREM®
(ro-Zair-em)
(ramelteon)

Read the Medication Guide that comes with ROZEREM (ramelteon) before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.

What is the most important information I should know about ROZEREM (ramelteon) ?

ROZEREM (ramelteon) may cause severe allergic reactions.

Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking ROZEREM (ramelteon) .

After taking ROZEREM (ramelteon) , 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 ROZEREM (ramelteon) . Activities may include:

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

Call your doctor right away if you find out that you have done any of the above activities after taking ROZEREM (ramelteon) .

Important:

1. Take ROZEREM (ramelteon) exactly as prescribed
   •  Do not take more ROZEREM (ramelteon) than prescribed.
   •  Take ROZEREM (ramelteon) within 30 minutes of going to bed, not sooner.
2. Do not take ROZEREM (ramelteon) 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 ROZEREM (ramelteon) with your other medicines
   •  cannot get a full night's sleep

WHAT IS ROZEREM (ramelteon) ?

ROZEREM (ramelteon) is a hypnotic (sleep) medicine. ROZEREM (ramelteon) is used in adults for the treatment of the symptom of trouble falling asleep from insomnia.

ROZEREM (ramelteon) is not for children.

Who should not take ROZEREM (ramelteon) ?

Do not take ROZEREM (ramelteon) if you are allergic to anything in it. See the end of this Medication Guide for a complete list of ingredients in ROZEREM (ramelteon) .

Do not take ROZEREM (ramelteon) if you are currently taking Luvox (fluvoxamine).

ROZEREM (ramelteon) may not be right for you. Before starting ROZEREM (ramelteon) , tell your doctor about all of your health conditions, including if you:

• have a history of depression, mental illness, or suicidal thoughts
• have liver disease
• have a lung disease or breathing problems
• are pregnant, planning to become pregnant, or breastfeeding

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects.

Do not take ROZEREM (ramelteon) with:

• • other medicines that can make you sleepy
• • Luvox® (fluvoxamine)

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

How should I take ROZEREM (ramelteon) ?

• Take ROZEREM (ramelteon) exactly as prescribed. Do not take more ROZEREM (ramelteon) than prescribed for you.
• Do not break the tablets. They should be swallowed whole.
• • Take ROZEREM (ramelteon) within 30 minutes of going to bed.
  After taking ROZEREM (ramelteon) only do activities to get ready for bed.
• Do not take ROZEREM (ramelteon) with or right after a meal.
• • Do not take ROZEREM (ramelteon) unless you are able to get a full night's sleep before you must be active again.
• Call your doctor if your insomnia worsens or is not better within 7-10 days. This may mean that there is another condition causing your sleep problems.
• If you take too much ROZEREM (ramelteon) or overdose, call your doctor or poison control center right away, or get emergency treatment.

What are the possible side effects of ROZEREM (ramelteon) ?

Possible serious side effects of ROZEREM (ramelteon) include:

• severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking ROZEREM (ramelteon) .
• getting out of bed while not being fully awake and do an activity that you do not know you are doing. (See "What is the most important information I should know about ROZEREM (ramelteon) ?")
• abnormal thoughts and behavior. Symptoms include worsening of depression, suicidal thoughts or actions, nightmares, and hallucinations.
• hormone effects. ROZEREM (ramelteon) can decrease testosterone levels and increase prolactin levels in the blood. Symptoms of low testosterone or high prolactin levels are:
  • decreased interest in sex
  • problems getting pregnant
  • irregular menstrual periods or no menstrual periods
  • leakage of milk from the nipples of a person who is not breastfeeding

Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using ROZEREM (ramelteon) . Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The most common side effects of ROZEREM (ramelteon) are:

• drowsiness
• tiredness
• dizziness
• You may still feel drowsy the next day after taking ROZEREM (ramelteon) . Do not drive or do other dangerous activities after taking ROZEREM (ramelteon) until you feel fully awake.

These are not all the side effects of ROZEREM (ramelteon) . Ask your doctor or pharmacist for more information.

How should I Store ROZEREM (ramelteon) ?

• Store ROZEREM (ramelteon) tablets at room temperature, 59° to 86° F (15° to 30°C). Keep the container tightly closed and protected from moisture and humidity.
• Keep ROZEREM (ramelteon) and all medicines out of reach of children.

General Information about ROZEREM (ramelteon)

• Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
• Do not use ROZEREM (ramelteon) for a condition for which it was not prescribed.
• Do not share ROZEREM (ramelteon) with other people, even if you think they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about ROZEREM (ramelteon) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ROZEREM (ramelteon) that is written for healthcare professionals. For more information about ROZEREM (ramelteon) , please call Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 or visit www.rozerem (ramelteon) .com.

What are the ingredients in ROZEREM?

Active Ingredient: ramelteon

Inactive Ingredients: lactose monohydrate, starch, hydroxypropyl cellulose, magnesium stearate, hypromellose, copovidone, titanium dioxide, yellow ferric oxide, polyethylene glycol 8000, and ink containing shellac and synthetic iron oxide black.

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

You should not use this medication if you are allergic to ramelteon, or if you have severe liver disease.

You should not take ramelteon if you are also taking the antidepressant fluvoxamine (Luvox).

To make sure you can safely take ramelteon, tell your doctor if you have any of these other conditions:

• liver disease;
• sleep apnea (breathing stops while you are asleep);
• a breathing disorder such as chronic obstructive pulmonary disease (COPD); or
• a history of depression, mental illness, or suicidal thoughts.

FDA pregnancy category C. It is not known whether ramelteon will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether ramelteon passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Ramelteon may affect the levels of male or female hormones (testosterone or prolactin). This may affect menstrual periods in women, sexual desire in men, or fertility (ability to have children) in either a man or a woman.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of ramelteon.

Rozerem is a prescription sleep medicine. It is for adults that have insomnia, particularly difficulty falling asleep. Unlike many sleep medications, Rozerem is not habit-forming. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Takeda Pharmaceuticals America, Inc.

Rozerem may cause severe allergic reactions. Symptoms include:

• swelling of the tongue or throat
• trouble breathing
• nausea
• vomiting

Seek emergency medical attention if you get these symptoms after taking Rozerem. Do not take Rozerem if you are allergic to any of the ingredients in Rozerem.

After taking Rozerem, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing including:

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

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 Rozerem. Call your doctor right away if you find out that you have done any of the above activities after taking Rozerem.

Take Rozerem about 30 minutes before going to bed. Do not take it sooner. Take Rozerem if you can get a full night's sleep. Take Rozerem exactly as prescribed. Never take more than prescribed.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Ramelteon is a sedative, also called a hypnotic. It works by affecting certain substances in your body that help regulate your "sleep-wake cycle."

Ramelteon is used to treat insomnia that is associated with having trouble falling asleep.

Unlike some other sleep medications, ramelteon is not known to be habit-forming.

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

Ramelteon will make you fall asleep. Never take this medicine during your normal waking hours, unless you have at least 7 to 8 hours to dedicate to sleeping.

You should not use ramelteon if you are allergic to it, or if:

• you have severe liver disease; or

• you also take fluvoxamine (Luvox).

To make sure ramelteon is safe for you, tell your doctor if you have:

• liver disease;

• sleep apnea (breathing stops while you are asleep);

• a breathing disorder such as chronic obstructive pulmonary disease (COPD); or

• a history of depression, mental illness, or suicidal thoughts.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether ramelteon passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Ramelteon may affect the levels of male or female hormones (testosterone or prolactin). This may affect menstrual periods in women, sexual desire in men, or fertility (ability to have children) in either a man or a woman.

Ramelteon is not approved for use by anyone younger than 18 years old.

Administration

Oral Administration

Administer orally within 30 minutes of bedtime.1 2

Avoid administration with or immediately after a high-fat meal because of potentially decreased rate of absorption.1 2 (See Food under Pharmacokinetics.)

Dosage

Adults

8 mg.1 2

Special Populations

Hepatic Impairment

Increased exposure to drug and active metabolite.1 (See Special Populations under Pharmacokinetics.) No specific dosage recommendations at this time.1 However, use with caution in patients with moderate hepatic impairment; avoid use in patients with severe hepatic impairment.1

Renal Impairment

No dosage adjustment necessary in patients with mild, moderate, or severe renal impairment or in those requiring chronic hemodialysis.1

In the U.S.

• Rozerem

Available Dosage Forms:

• Tablet

Therapeutic Class: Nonbarbiturate Hypnotic

Pharmacologic Class: Melatonin Receptor Agonist

It is best to take this medicine no more than 30 minutes before you go to bed. After you take the medicine do not engage in any activity besides getting ready for bed.

Do not take this medicine with or right after a meal.

Swallow the tablet whole. Do not break it.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For the treatment of insomnia (trouble in sleeping):
    • Adults—8 milligrams (mg) at bedtime.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Patients who develop angioedema after treatment with Rozerem should not be rechallenged with the drug.

Patients should not take Rozerem in conjunction with fluvoxamine (Luvox) [see Drug Interaction (7)].

Severe Anaphylactic and Anaphylactoid Reactions

Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of Rozerem. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with Rozerem should not be rechallenged with the drug.

Need to Evaluate for Co-morbid Diagnoses

Since sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia, or the emergence of new cognitive or behavioral abnormalities, may be the result of an unrecognized underlying psychiatric or physical disorder and requires further evaluation of the patient. Exacerbation of insomnia and emergence of cognitive and behavioral abnormalities were seen with Rozerem during the clinical development program.

Abnormal Thinking and Behavioral Changes

A variety of cognitive and behavior changes have been reported to occur in association with the use of hypnotics. In primarily depressed patients, worsening of depression (including suicidal ideation and completed suicides) has been reported in association with the use of hypnotics.

Hallucinations, as well as behavioral changes such as bizarre behavior, agitation and mania have been reported with Rozerem use. Amnesia, anxiety and other neuro-psychiatric symptoms may also occur unpredictably.

Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a hypnotic) and other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex), with amnesia for the event, have been reported in association with hypnotic use. The use of alcohol and other CNS depressants may increase the risk of such behaviors. These events can occur in hypnotic-naive as well as in hypnotic-experienced persons. Complex behaviors have been reported with the use of Rozerem. Discontinuation of Rozerem should be strongly considered for patients who report any complex sleep behavior.

CNS Effects

Patients should avoid engaging in hazardous activities that require concentration (such as operating a motor vehicle or heavy machinery) after taking Rozerem.

After taking Rozerem, patients should confine their activities to those necessary to prepare for bed.

Patients should be advised not to consume alcohol in combination with Rozerem as alcohol and Rozerem may have additive effects when used in conjunction.

Reproductive Effects

Use in Adolescents and Children

Rozerem has been associated with an effect on reproductive hormones in adults, e.g., decreased testosterone levels and increased prolactin levels. It is not known what effect chronic or even chronic intermittent use of Rozerem may have on the reproductive axis in developing humans [see Clinical Trials (14.3)].

Use in Patients with Concomitant Illness

Rozerem has not been studied in subjects with severe sleep apnea and is not recommended for use in this population [see Use in Specific Populations (8.7)].

Rozerem should not be used by patients with severe hepatic impairment [see Clinical Pharmacology (12.4)].

Laboratory Tests

Monitoring

No standard monitoring is required.

For patients presenting with unexplained amenorrhea, galactorrhea, decreased libido, or problems with fertility, assessment of prolactin levels and testosterone levels should be considered as appropriate.

Interference with Laboratory Tests

Rozerem is not known to interfere with commonly used clinical laboratory tests. In addition, in vitro data indicate that ramelteon does not cause false-positive results for benzodiazepines, opiates, barbiturates, cocaine, cannabinoids, or amphetamines in two standard urine drug screening methods in vitro.

Controlled Clinical Trials

Chronic Insomnia

Three randomized, double-blind trials in subjects with chronic insomnia employing polysomnography (PSG) were provided as objective support of Rozerem's effectiveness in sleep initiation.

One study enrolled younger adults (aged 18 to 64 years, inclusive) with chronic insomnia and employed a parallel design in which the subjects received a single, nightly dose of Rozerem (8 mg or 16 mg) or matching placebo for 35 days. PSG was performed on the first two nights in each of Weeks 1, 3, and 5 of treatment. Rozerem reduced the average latency to persistent sleep at each of the time points when compared to placebo. The 16 mg dose conferred no additional benefit for sleep initiation.

The second study employing PSG was a three-period crossover trial performed in subjects aged 65 years and older with a history of chronic insomnia. Subjects received Rozerem (4 mg or 8 mg) or placebo and underwent PSG assessment in a sleep laboratory for two consecutive nights in each of the three study periods. Both doses of Rozerem reduced latency to persistent sleep when compared to placebo.

The third study evaluated long term efficacy and safety in adults with chronic insomnia. Subjects received a single, nightly dose of Rozerem 8 mg or matching placebo for 6 months. PSG was performed on the first two nights of Week 1 and Months 1, 3, 5, and 6. Rozerem reduced sleep latency at each time point when compared to placebo. In this study, when the PSG results from nights 1 and 2 of Month 7 were compared to the results from nights 22 and 23 of Month 6, there was a statistically significant increase in LPS of 33% (9.5 minutes) in the ramelteon group. There was no increase in LPS in the placebo group when the same time periods were compared.

A randomized, double-blind, parallel group study was conducted in outpatients aged 65 years and older with chronic insomnia and employed subjective measures of efficacy (sleep diaries). Subjects received Rozerem (4 mg or 8 mg) or placebo for 35 nights. Rozerem reduced patient-reported sleep latency compared to placebo. A similarly designed study performed in younger adults (aged 18 - 64 years) using 8 mg and 16 mg of ramelteon did not replicate this finding of reduced patient-reported sleep latency compared to placebo.

While the 16 mg dose was evaluated as a potential treatment for adults, it was shown to confer no additional benefit for sleep initiation and was associated with higher incidences of fatigue, headache and next-day somnolence.

Transient Insomnia

In a randomized, double-blind, parallel-group trial using a first-night-effect model, healthy adults received placebo or Rozerem before spending one night in a sleep laboratory and being evaluated with PSG. Rozerem demonstrated a decrease in mean latency to persistent sleep as compared to placebo.

Studies Pertinent to Safety Concerns for Sleep- promoting Drugs

Results from Human Laboratory Abuse Liability Studies

A human laboratory abuse potential study was performed in 14 subjects with a history of sedative/hypnotic or anxiolytic drug abuse. Subjects received single oral doses of Rozerem (16, 80, or 160 mg), triazolam (0.25, 0.50, or 0.75 mg) or placebo. All subjects received each of the 7 treatments separated by a wash-out period and underwent multiple standard tests of abuse potential. No differences in subjective responses indicative of abuse potential were found between Rozerem and placebo at doses up to 20 times the recommended therapeutic dose. The positive control drug, triazolam, consistently showed a dose-response effect on these subjective measures, as demonstrated by the differences from placebo in peak effect and overall 24-hour effect.

Residual Pharmacological Effect in Insomnia Trials

In order to evaluate potential next-day residual effects, the following scales were used: a Memory Recall Test, a Word List Memory Test, a Visual Analog Mood and Feeling Scale, the Digit-Symbol Substitution Test, and a post-sleep questionnaire to assess alertness and ability to concentrate. There was no evidence of next-day residual effect seen after 2 nights of ramelteon use during the crossover studies.

In a 35-night, double-blind, placebo-controlled, parallel-group study in adults with chronic insomnia, measures of residual effects were performed at three time points. Overall, the magnitudes of any observed differences were small. At Week 1, patients who received 8 mg of Rozerem had a mean VAS score (46 mm on a 100 mm scale) indicating more fatigue in comparison to patients who received placebo (42 mm). At Week 3, patients who received 8 mg of Rozerem had a lower mean score for immediate recall (7.5 out of 16 words) compared to patients who received placebo (8.2 words); and the patients treated with Rozerem had a mean VAS score indicating more sluggishness (27 mm on a 100 mm VAS) in comparison to the placebo-treated patients (22 mm). Patients who received Rozerem did not have next-morning residual effects that were different from placebo at Week 5.

Rebound Insomnia/Withdrawal

Potential rebound insomnia and withdrawal effects were assessed in four studies in which subjects received Rozerem or placebo for up to 6 months; 3 were 35-day studies, one was a 6 month study. These studies included a total of 2533 subjects, of whom 854 were elderly.

Tyrer Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ): The BWSQ is a self-report questionnaire that solicits specific information on 20 symptoms commonly experienced during withdrawal from benzodiazepine receptor agonists; Rozerem is not a benzodiazepine receptor agonist.

In two of the three 35-day insomnia studies, the questionnaire was administered one week after completion of treatment; in the third study, the questionnaire was administered on Days 1 and 2 after completion. In all three of the 35-day studies, subjects receiving Rozerem 4 mg, 8 mg, or 16 mg daily reported BWSQ scores similar to those of subjects receiving placebo.

In the 6 month study, there was no evidence of withdrawal from the 8 mg dose as measured by the BWSQ.

Rebound Insomnia: Rebound insomnia was assessed in the 35-day studies by measuring sleep latency after abrupt treatment discontinuation. One of these studies employed PSG in younger adult subjects receiving Rozerem 8 mg or 16 mg; the other two studies employed subjective measures of sleep-onset insomnia in elderly subjects receiving Rozerem 4 mg or 8 mg, and in younger adult subjects receiving Rozerem 8 mg or 16 mg. There was no evidence that Rozerem caused rebound insomnia during the post-treatment period.

Studies to Evaluate Effects on Endocrine Function

Two controlled studies evaluated the effects of Rozerem on endocrine function.

In the first trial, Rozerem 16 mg once daily or placebo was administered to 99 healthy volunteer subjects for 4 weeks. This study evaluated the thyroid axis, adrenal axis and reproductive axis. No clinically significant endocrinopathies were demonstrated in this study. However, the study was limited in its ability to detect such abnormalities due to its limited duration.

In the second trial, Rozerem 16 mg once daily or placebo was administered to 122 subjects with chronic insomnia for 6 months. This study evaluated the thyroid axis, adrenal axis and reproductive axis. There were no significant abnormalities seen in either the thyroid or the adrenal axes. Abnormalities were, however, noted within the reproductive axis. Overall, the mean serum prolactin level change from baseline was 4.9 mcg/L (34% increase) for women in the Rozerem group compared with -0.6 mcg/L (4% decrease) for women in the placebo group (p=0.003). No differences between active- and placebo-treated groups occurred among men. Thirty-two percent of all patients who were treated with ramelteon in this study (women and men) had prolactin levels that increased from normal baseline levels compared to 19% of patients who were treated with placebo. Subject-reported menstrual patterns were similar between the two treatment groups.

In a 12-month, open-label study in adult and elderly patients, there were two patients who were noted to have abnormal morning cortisol levels, and subsequent abnormal ACTH stimulation tests. A 29-year-old female patient was diagnosed with a prolactinoma. The relationship of these events to Rozerem therapy is not clear.

Take Rozerem exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take Rozerem 30 minutes before your normal bedtime. After you take this medicine, avoid doing anything other than getting ready for bed.

Do not crush, chew, or break the tablet. Swallow it whole.

Avoid taking Rozerem together with or just after eating a high-fat meal. This will make it harder for your body to absorb the medication.

Call your doctor if your symptoms do not improve after 7 to 10 days of using Rozerem.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.