Night Calm Uses

• Night Calm indications
• Uses of Night Calm in details
• Night Calm description
• Night Calm dosage
• Night Calm interactions
• Night Calm side effects
• Night Calm contraindications

What is Night Calm?

Night Calm is a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia).

Night Calm is used to treat insomnia. This medicine causes relaxation to help you fall asleep and stay asleep.

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

Night Calm indications

Night Calm tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, Night Calm tablets administered at bedtime decreased sleep latency and improved sleep maintenance.

The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6 week study (adults only), at the end of both 2 week studies (elderly only) and at the end of the 6 month study (adults only).

How should I use Night Calm?

Use Night Calm as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Night Calm comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Night Calm refilled.
• Take Night Calm by mouth. Do not take Night Calm with, or immediately after, a meal.
• Night Calm works very quickly. Take it right before getting into bed. This will help to decrease the risk of falling and other side effects.
• If you miss a dose of Night Calm and you are taking 1 dose daily at bedtime, skip the missed dose. Do not take the dose in the morning or take 2 doses at once.

Ask your health care provider any questions you may have about how to use Night Calm.

Uses of Night Calm in details

Night Calm is used to treat sleep related problems like difficulty falling asleep or staying asleep (insomnia).

Night Calm description

Night Calm, marketed by Sepracor under the brand-name Lunesta, is a nonbenzodiazepine hypnotic agent (viz., a sedative) used as a treatment for insomnia. Night Calm is the active stereoisomer of zopiclone, and belongs to the class of drugs known as cyclopyrrones. Its main selling point is that it is approved by the U.S. Food and Drug Administration for long-term use, unlike almost all other hypnotic sedatives, which are approved only for the relief of short-term (6-8 weeks) insomnia.

Night Calm dosage

Use the lowest effective dose for the patient.

Dosage in Adults

The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or 3 mg if clinically indicated. In some patients, the higher morning blood levels of Night Calm tablets following use of the 2 mg or 3 mg dose increase the risk of next day impairment of driving and other activities that require full alertness. The total dose of Night Calm tablets should not exceed 3 mg, once daily immediately before bedtime.

Geriatric or Debilitated Patients

The total dose of Night Calm tablets should not exceed 2 mg in elderly or debilitated patients.

Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors

In patients with severe hepatic impairment, or in patients coadministered Night Calm tablets with potent CYP3A4 inhibitors, the total dose of Night Calm tablets should not exceed 2 mg.

Use with CNS Depressants

Dosage adjustments may be necessary when Night Calm tablets are combined with other CNS depressant drugs because of the potentially additive effects.

Administration with Food

Taking Night Calm tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of Night Calm tablets on sleep latency.

Night Calm interactions

See also:
What other drugs will affect Night Calm?

CNS-Active Drugs

Ethanol

An additive effect on psychomotor performance was seen with coadministration of Night Calm and ethanol 0.70 g/kg for up to 4 hours after ethanol administration.

Paroxetine

Coadministration of single doses of Night Calm 3 mg and paroxetine 20 mg daily for 7 days produced no pharmacokinetic or pharmacodynamic interaction.

Lorazepam

Coadministration of single doses of Night Calm 3 mg and lorazepam 2 mg did not have clinically relevant effects on the pharmacodynamics or pharmacokinetics of either drug.

Olanzapine

Coadministration of Night Calm 3 mg and olanzapine 10 mg produced a decrease in DSST scores. The interaction was pharmacodynamic; there was no alteration in the pharmacokinetics of either drug.

Drugs That Inhibit CYP3A4 (Ketoconazole)

CYP3A4 is a major metabolic pathway for elimination of Night Calm. The AUC of Night Calm was increased 2.2-fold by coadministration of ketoconazole, a potent inhibitor of CYP3A4, 400 mg daily for 5 days. C_max and t_1/2 were increased 1.4-fold and 1.3-fold, respectively. Other strong inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, nefazodone, troleandomycin, ritonavir, nelfinavir) would be expected to behave similarly.

Drugs That Induce CYP3A4 (Rifampicin)

Racemic zopiclone exposure was decreased 80% by concomitant useof rifampicin, a potent inducer of CYP3A4. A similar effect would be expected with Night Calm.

Drugs Highly Bound To Plasma Protein

Night Calm is not highly bound to plasma proteins (52-59% bound); therefore, the disposition of Night Calm is not expected to be sensitive to alterations in protein binding. Administration of Night Calm 3 mg to a patient taking another drug that is highly protein-bound would not be expected to cause an alteration in the free concentration of either drug.

Drugs With A Narrow Therapeutic Index

Digoxin

A single dose of Night Calm 3 mg did not affect the pharmacokinetics of digoxin measured at steady state following dosing of 0.5 mg twice daily for one day and 0.25 mg daily for the next 6 days.

Warfarin

Night Calm 3 mg administered daily for 5 days did not affect the pharmacokinetics of (R)- or (S)-warfarin, nor were there any changes in the pharmacodynamic profile (prothrombin time) following a single 25 mg oral dose of warfarin.

Night Calm side effects

See also:
What are the possible side effects of Night Calm?

Applies to Night Calm: oral tablet

In addition to its needed effects, some unwanted effects may be caused by Night Calm. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Night Calm:

More common:

• Cough or hoarseness
• fever or chills
• lower back or side pain
• painful or difficult urination
• sleepiness or unusual drowsiness

• Bladder pain
• bloody or cloudy urine
• cold flu-like symptoms
• confusion
• difficult, burning, or painful urination
• discouragement
• fear or nervousness
• feeling sad or empty
• frequent urge to urinate
• irritability
• lack of appetite
• loss of interest or pleasure
• nerve pain
• seeing, hearing, or feeling things that are not there
• tiredness
• trouble concentrating
• trouble sleeping

Minor Side Effects

Some of the side effects that can occur with Night Calm may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:

• Acid or sour stomach
• bad, unusual, or unpleasant (after) taste
• belching
• change in taste
• dizziness
• dry mouth
• headache
• heartburn
• indigestion
• nausea
• pain
• stomach discomfort, upset, or pain

• Abnormal dreams
• accidental injury
• decreased interest in sexual intercourse
• diarrhea
• inability to have or keep an erection
• pain, cramps, or heavy bleeding (females)
• rash
• swelling of the breasts or breast soreness (in both males and females)
• vomiting

• Loss of memory
• problems with memory

Night Calm contraindications

See also:
What is the most important information I should know about Night Calm?

Night Calm hydrochloride is contraindicated in patients with known hypersensitivity to the drug.

Usage in Pregnancy: Benzodiazepines may cause fetal damage when administered during pregnancy. An increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies.

Night Calm hydrochloride is contraindicated in pregnant women. Symptoms of neonatal depression have been reported; a neonate whose mother received 30 mg of flurazepam hydrochloride nightly for insomnia during the 10 days prior to delivery appeared hypotonic and inactive during the first four days of life. Serum levels of N1-desalkyl-flurazepam in the infant indicated transplacental circulation and implicate this long-acting metabolite in this case. If there is a likelihood of the patient becoming pregnant while receiving flurazepam, she would be warned of the potential risks to the fetus. Patients should be instructed to discontinue the drug prior to becoming pregnant. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered.

Active ingredient matches for Night Calm:

Eszopiclone in Egypt.

References

1. DailyMed. "ESZOPICLONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubChem. "Eszopiclone". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "Eszopiclone". http://www.drugbank.ca/drugs/DB00402 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology