Print（PDF/105KB） Feb. 20, 2012 Products

Dainippon Sumitomo Pharma obtains manufacturing and marketing approval for Sleep Inducing Treatment "Zolpidem tartrate tablets 5mg/10mg [DSP]"

Dainippon Sumitomo Pharma Co., Ltd. (DSP) (Headquarters: Osaka, Japan; President: Masayo Tada) announces that as of February 15, 2012, DSP has obtained manufacturing and marketing approval for the sleep inducing treatment "Zolpidem tartrate tablets 5mg/10mg [DSP]" in Japan from the Ministry of Health, Labour and Welfare. These two products are scheduled to be launched after NHI price listing.

In the pharmaceutical business in Japan, DSP designates the Central Nervous System field as one of its focus marketing areas, and offers various treatments such as atypical antipsychotics "LONASEN^®" and "LULLAN^®", Parkinson's disease drug "TREREIF^®", norepinephrine-activating neural function ameliorant "DOPS^®", anti-epileptic drug "EXCEGRAN^®", and serotonin-agonist antianxiety drug "SEDIEL^®" and is currently engaging in activities to provide information on these products.

Moreover, as part of a plan to strengthen the lineup in the CNS area, DSP is handling generic drugs in this therapeutic area. In December 2011, DSP launched Donepezil hydrochloride tablets/OD tablets 3mg/5mg [DSP] in Japan. This time, adding Zolpidem tartrate tablets 5mg/10mg [DSP] to the product lineup through its approval, DSP intends to further meet the diverse needs of medical personnel in the CNS area.

In the future, DSP will positively introduce products to contribute to the treatment of CNS disorders regardless of whether they are new or generic drugs.

Attached reference: Profile of "Zolpidem tartrate tablets 5mg/10mg [DSP] "

<Reference>

Profile of "Zolpidem tartrate tablets 5mg/10mg [DSP]"

[Product Name]	Zolpidem tartrate tablets 5mg [DSP] Zolpidem tartrate tablets 10mg [DSP]
[Generic Name]	zolpidem tartrate
[Content / Description]	Zolpidem tartrate tablets 5mg/10mg [DSP]: film-coated tablets containing 5mg or 10mg of zolpidem tartrate, with a score line on one side.
[Indication]	Insomnia. (Except insomnia associated with schizophrenia and manic-depressive psychosis)
[Dose and Administration]	The usual adult dose is once daily 5 to 10mg of zolpidem tartrate administered orally immediately before bedtime. It should be noted that the initial dose for elderly patients is from 5mg once daily. The dosage may be adjusted depending on age, symptoms, disease, and should not exceed 10mg once daily.
[Manufacturer and Distributor]	Dainippon Sumitomo Pharma Co., Ltd.