Content about Insomnia

March 5, 2013

Procter & Gamble’s Downy and ZzzQuil brands have joined forces to help consumers create an environment that is conducive for falling asleep in time for National Sleep Awareness Week March 3-10.

CINCINNATI — Procter & Gamble’s Downy and ZzzQuil brands have joined forces to help consumers create an environment that is conducive for falling asleep in time for National Sleep Awareness Week March 3 to 10. 

According to a recent poll by the National Sleep Foundation, 1-in-4 adults report occasional sleeplessness with difficulty falling asleep at least a few times a week. 

February 7, 2013

An insomnia drug made by Purdue Pharma "significantly" reduced the time it took patients to return to sleep after they'd woke up in the middle of the night, according to a new study.

STAMFORD, Conn. — An insomnia drug made by Purdue Pharma "significantly" reduced the time it took patients to return to sleep after they'd woke up in the middle of the night, according to a new study.

The placebo-controlled study, published in the journal Sleep, tested the drug Intermezzo (zolpidem tartrate) sublingual tablets on 295 adults with primary insomnia and difficulty returning to sleep after waking up in the middle of the night. Purdue said Intermezzo was the only drug approved by the Food and Drug Administration for treating such patients.

January 10, 2013

The Food and Drug Administration is ordering the makers of several sleep drugs to lower the dosage due to the risk that they can impair patients the morning after, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration is ordering the makers of several sleep drugs to lower the recommended dosage due to the risk that they can impair patients the morning after, the agency said Thursday.

The FDA announced that it was requiring the manufacturers of drugs containing the active ingredient zolpidem to lower the current recommended dosage in light of new data showing that the morning after use, the drug can remain in the blood in sufficient quantities to impair activities that require alertness, such as driving.

November 8, 2012

The Food and Drug Administration has accepted an application from Merck for an experimental drug for insomnia, the drug maker said Thursday.

WHITEHOUSE STATION, N.J. — The Food and Drug Administration has accepted an application from Merck for an experimental drug for insomnia, the drug maker said Thursday.

Merck announced the the FDA's acceptance of its regulatory filing for suvorexant, which the FDA's Controlled Substances Staff will review while the agency is reviewing the application.

September 10, 2012

A study of an experimental drug for insomnia indicated that patients who stop taking it continue having sleeping problems, according to results of a clinical trial announced Monday.

WHITEHOUSE STATION, N.J. — A study of an experimental drug for insomnia indicated that patients who stop taking it continue having sleeping problems, according to results of a clinical trial announced Monday.

Merck released data from a phase-3 trial of suvorexant in which patients who had been taking the drug daily for a year were switched to placebo for a two-month "discontinuation phase." Patients who were switched from the drug to placebo showed sleeping difficulties similar to those who had consistently taken placebo.

July 18, 2012

Mylan has settled a patent litigation suit filed by Somaxon Pharmaceutical concerning an insomnia drug, Mylan said.

PITTSBURGH — Mylan has settled a patent litigation suit filed by Somaxon Pharmaceutical concerning an insomnia drug, Mylan said.

The generic drug maker said that under the settlement, it would have the right to sell doxepin hydrochloride tablets in the 3-mg and 6-mg strengths starting in January 2020. The drug is a generic version of Somaxon's Silenor.

June 18, 2012

Procter & Gamble on Monday officially announced the introduction of ZzzQuil, a sleep aid addition to its Vicks NyQuil and Vicks DayQuil brands.

CINCINNATI — Procter & Gamble on Monday officially announced the introduction of ZzzQuil, a sleep aid addition to its Vicks NyQuil and Vicks DayQuil brands.

“ZzzQuil not only helps reduce the time it takes for a person to fall asleep, but [also] allows them to sleep soundly so they can wake up rested and refreshed,” stated Dave Tomasi, marketing director of North America for Vicks. “It is a sleep-only solution that delivers effective relief to consumers suffering from occasional sleeplessness.”

June 13, 2012

Merck on Wednesday released new data from two pivotal Phase III efficacy trials for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia.

BOSTON — Merck on Wednesday released new data from two pivotal Phase III efficacy trials for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia.

Merck expects to file a new drug application to the Food and Drug Administration in 2012. If approved, suvorexant would be the first medicine approved in a new class of medicines, called orexin receptor antagonists, for use in patients with difficulty falling or staying asleep. Merck anticipates that suvorexant will be evaluated by the Controlled Substance Staff of the FDA.

November 23, 2011

The Food and Drug Administration has approved the first drug for insomnia in which patients wake in the middle of the night and have trouble returning to sleep.

SILVER SPRING, Md. — The Food and Drug Administration has approved the first drug for insomnia in which patients wake in the middle of the night and have trouble returning to sleep.

October 4, 2011

Insomnnia may be the next big treatment regimen to make a switch from prescription-only to over the counter.

SAN DIEGO — Insomnnia may be the next big treatment regimen to make a switch from prescription-only to over the counter.

June 7, 2011

The Food and Drug Administration has given final approval to a generic drug for insomnia made by Actavis, the drug maker said Monday.

MORRISTOWN, N.J. — The Food and Drug Administration has given final approval to a generic drug for insomnia made by Actavis, the drug maker said Monday.

The FDA approved the company’s zolpidem tartrate extended-release tablets in the 12.5-mg strength. The drug, which is a Schedule IV controlled substance, is a generic version of Sanofi’s Ambien CR. Actavis was the first company to launch a generic version of the drug in the 6.25-mg strength in October 2010.

February 4, 2011

Hi-Tech Pharmacal subsidiary ECR Pharmaceuticals has launched a drug for treating insomnia.

AMITYVILLE, N.Y. — Hi-Tech Pharmacal subsidiary ECR Pharmaceuticals has launched a drug for treating insomnia.

ECR announced Friday the launch of Zolpimist (zolpidem tartrate) oral spray. The drug comes in units that provide 60 metered sprays, administering 5-mg or 10-mg doses of the active ingredient. As a hypnotic agent, the drug is classified as a CIV controlled substance by the federal government.

January 18, 2011

Transcept Pharmaceuticals has resubmitted its regulatory application for a drug to treat insomnia to the Food and Drug Administration, following a previous denial of approval by the agency, the drug maker said Tuesday.

POINT RICHMOND, Calif. — Transcept Pharmaceuticals has resubmitted its regulatory application for a drug to treat insomnia to the Food and Drug Administration, following a previous denial of approval by the agency, the drug maker said Tuesday.

Transcept sent in its application for Intermezzo (zolpidem tartrate), a pill placed under the tongue for treating patients who awake in the middle of the night and have difficulty falling asleep again.

October 18, 2010

The Food and Drug Administration has approved a drug for treating insomnia made by Actavis,...

MORRISTOWN, N.J. The Food and Drug Administration has approved a drug for treating insomnia made by Actavis, the generic drug maker said Monday.

 

Actavis announced the approval of zolpidem tartrate extended-release tablets in the 6.25-mg strength. The company has begun shipping the drug.

 

 

The drug is a generic version of Sanofi-Aventis’ Ambien CR, which had sales of around $129 million during the 12-month period ended in June, according to IMS Health.

 

September 6, 2010

Drug maker Somaxon Pharmaceuticals has made its treatment for insomnia available by prescription, the company...

SAN DIEGO Drug maker Somaxon Pharmaceuticals has made its treatment for insomnia available by prescription, the company said Tuesday.

 

Somaxon announced the availability of Silenor (doxepin), which received approval from the Food and Drug Administration in March as a treatment for insomnia characterized by difficulty with sleep maintenance.

 

 

June 16, 2010

An investigational treatment made by Merck for insomnia was more effective than placebo in improving...

June 8, 2010

Nature Made officially launched its natural sleep aid this week....

May 16, 2010

More relaxation drinks are trickling into the market. The beverages, designed to be stress-reducing, have...

MEMPHIS, Tenn. —More relaxation drinks are trickling into the market. The beverages, designed to be stress-reducing, have become popular with consumers looking for an anti-energy choice. The drinks were named a top trend for 2010 on both “The View” and “Good Morning America.”

March 21, 2010

Lupin has received tentative approval for a generic version of a popular insomnia treatment....